Director Regulatory Resume Samples

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R Keeling

Regan

Keeling

858 Grant Crest

Chicago

+1 (555) 443 3297

858 Grant Crest

Chicago

Phone

p +1 (555) 443 3297

Experience Experience

Los Angeles, CA

Audit Director, Regulatory Reform

Los Angeles, CA

Mueller-Ziemann

Los Angeles, CA

Audit Director, Regulatory Reform

Delivers learning and development programs and is a recognized leader in training and developing others
Develops approaches to promote knowledge sharing and promulgate management best practices across Internal Audit and both Citibank and Citigroup
Leads the professional development of Internal Audit staff
Participates in major business initiatives and pro-actively advises and assists the business on change initiatives
Applies comprehensive expertise in one or more of the corporation's businesses and leverages this knowledge into a leadership role in one or more teams
Delivers cost effective and efficient management of audit teams and audit engagements
Responsible for the delivery of high quality, value-added multiple concurrent audits on time and to specification

New York, NY

Director Regulatory Consulting Manager

New York, NY

Marks Group

New York, NY

Director Regulatory Consulting Manager

Lead and manage presentations for management
Provides overall project presentations in high quality
Strong executive presence and comfort working with senior executives
Manage overall quality and timeliness of project delivery
Solves client conflicts at senior executive management level
Writes sharp and straight-to-the-point management summaries
Manage and motivate resources at all levels

present

Detroit, MI

Executive Director, Regulatory Labeling

Detroit, MI

Shanahan Group

present

Detroit, MI

Executive Director, Regulatory Labeling

present

Leading cross-functional teams (LWG/ELB/SMT) in the development and maintenance of drug product labeling
Troubleshoots and solves any conflicts or issues on the critical path to reaching a labeling decision
Facilitates consensus among labeling teams and secures proper sign-off on labeling decisions
Responsible for drafting, editing, proofing and creating final corporate approved product labeling documents in corporate labeling document management system (EPIC)
Provides Regulatory Submissions (link/virtual document) of final approved labeling documents (Word and Structured Product Labeling (SPL) formatted labels) for agency submission
Leads cross-functional team discussion on the process for implementation of FDA approved product labeling (US prescribing and patient information and Dear Health Care Provider (DHCP) Letters)
Enters editorial corrections of relevant labeling changes in the Bin and Corrigendum System, in collaboration with Global Labeling Operations (GLO). GLO utilizes information for Annual Report of Minor Changes

Education Education

Bachelor’s Degree in Finance

Columbia University

Bachelor’s Degree in Finance

Skills Skills

Strong attention to detail and high standards for quality work product
Ability to interpret and analyze statistical data; comfort with excel and basic statistics
Demonstrable customer mindset
Proven ability to maintain composure in stressful situations
Experience in leading quality assurance efforts
Understanding of current regulations in the cable industry
Experience using and working with Tableau reporting platforms
Excellent analytical, problem-solving, and decision-making skills
Keen business process intuition, strong interpersonal skills, and a team-player approach
Experience collaborating and working successfully with multiple stakeholders and teams, and excelling in an entrepreneurial environment

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15 Director Regulatory resume templates

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Associate Director, Regulatory Solutions Resume Examples & Samples

Preparing Executive Summaries of relevant regulations; and
Conducting High Level Impact Assessments, which include information on the financial impact and potential revenue generation from the regulatory change
The escalation process consists of: Developing recommendations for regulatory project commencement and approval of preliminary funding
Preparing Preliminary Assessments to transition to Gate 3 of the Project Management Framework; and
Assisting in the preparation of financial and business plans to identify and analyze commercial opportunities
Partners with key business and functional groups to successfully manage evolving global regulatory developments for I&TS, including the following: Preparation of PARs for Regulatory Projects
Representing Regulatory Solutions on Regulatory Project Working Groups responsible for solution delivery and implementation
Assessing Regulatory Project closure and the achievement of regulatory requirements
Leads Regulatory Solutions’ communication plan and acts as key contact for marketing, client and employee regulatory communications: Develops and reviews employee and client regulatory communications
Oversees preparation of regulatory newsflashes and updates
Coordinates I&TS’ response to regulators’ requests for comments and participation in industry associations
10-15 years progressive financial industry experience
Strong understanding / knowledge of capital markets, investment fund and custody markets, banking sector and related industry regulations
Demonstrated understanding of regulatory / compliance risk and finance principles
Demonstrated knowledge of and experience in project management

Associate Director, Regulatory Assurance Resume Examples & Samples

The execution of Regulatory Assurance reviews in key areas identified by the risk assessment process and regional Compliance management team
Managing the conduct of special investigations
Communicating the results of reviews to senior management
Continually identifying efficiencies and driving initiatives to achieve a robust compliance framework; and
Proactively managing and developing more junior members of the Regulatory Assurance group

Audit Director, Regulatory Reform Resume Examples & Samples

Contribute to strategic direction of Citi’s Internal Audit (IA) function in the establishment of Regulatory Reform (e.g. Dodd Frank / Volcker) related risk based auditing which includes reporting methodologies, organizational design and effective positioning of the function to ensure provision of independent assurance. This is to be consistent and aligned with Citigroup and Citibank business objectives
Manages multiple teams of professionals. Recruits staff, develops talent, builds effective teams, and manages a budget. Identifies internal talent and fills key positions, attracts talent with required expertise to meet the risk profile of the business, builds deep bench strength and develops appropriate succession plans
Develops and executes a robust Audit Plan, by reviewable entity, for assigned businesses in accordance with Internal Audit standards, relevant government statutes and regulations and Citigroup and Citibank policies
Analyzes reporting findings; Recommends appropriate interventions where needed. Proposes creative and pragmatic solutions for risk and control problems. Partners with Directors and Managing Directors to develop approaches for addressing broader corporate emerging issues

Associate Director, Regulatory Product Lead Resume Examples & Samples

Minimum of 8 years in drug/biologics development in the US pharmaceutical and biotechnology industry or Government Health Agency
Demonstrated track record of successful management of submissions in US regulatory affairs is required. Prior regulatory agency liaison experience is preferred
Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred
Capable of managing multiple projects and complex timelines in a team environment
Excellent interpersonal, communication, analytical and organizational skills. Good negotiation skills essential
Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
Ability to work in a highly matrix working environment is important given the need to interact effectively with other GRA functions, internal departments and external organizations

Associate Director, Regulatory Resume Examples & Samples

Solid background in the biological sciences and the ability to apply that knowledge to complex drug development issues within the framework of applicable regulatory requirements
Strong knowledge of US regulations, including knowledge of GCP, GLP, and cGMP
Experience with all types of submissions, including INDs, NDA/MAAs, CTD and supplements. Ex-US submission experience preferred
Needs to have at least a MS Degree with a focus in a science- or health-related discipline with a minimum of 5 years pharmaceutical industry or related experience in the regulatory affairs environment

Associate Director Regulatory Onboarding Resume Examples & Samples

Operates autonomously to research and interpret regulatory reform initiatives that potentially impact client onboarding activities, and reports potential material impacts to management. Works with the Director & Head, Regulatory Onboarding to create a strategic plan to address evolving regulatory changes in a manner that is thoughtful, deliberate and seamless to affected stakeholders. Consistently demonstrates an expert knowledge of trading products and capital markets documentation requirements necessary to support the strategic plan
The incumbent effectively communicates and liaises with internal stakeholders (Legal, Compliance, Front Office, GWO, RMIT, PMO etc.) as well as a broad network of external contacts (external counsel, industry associations, etc.) as required to build consensus on the impact of regulatory reform to client onboarding
Takes ownership for driving the structuring and rollout of process changes to our client onboarding model required to meet regulatory requirements
Assists in the planning, creation and provision of the training tools necessary for onboarding teams to stay abreast of regulatory onboarding requirements as well as developing and implementing communication strategies of any process changes to affected stakeholders across the division
5-7 years’ industry experience in the capital markets, having covered multiple product areas and jurisdictions, either in the business or in a law firm environment. An LL.B./J.D. is highly desirable
A sound understanding of the capital markets business is necessary, as is a client-centric approach to the role. The international scope of the business, together with the multiplicity of stakeholders, will require work outside of traditional business hours from time to time
Excellent communication and organizational skills are critical to the role. Interaction with internal and external contacts includes GBM senior management, trading and marketing desks, corporate bankers, legal counsel, clients and industry players. Effective presentation skills are essential
Must be able to operate effectively within an exceptionally stressful environment with changing priorities and tight time frames which are closely scrutinized by Senior/Executive Management
The position requires strong business acumen, sound judgment and critical thinking skills. The incumbent must be an action-oriented and self-motivated multi-tasker who possesses strong relationship management skills. It is critical that the incumbent be equally adept at both strategizing and implementing process change

Associate Director Regulatory Initiatives Resume Examples & Samples

Monitoring GBM compliance with regulations
Compilation of management information reports on regulatory metrics for Trading Management and GBM Executives
Establish key risk indicators (KRIs) and document controls or processes
Provide Subject matter expertise in capital markets reform initiatives
Research and assess the business impact of regulatory reforms on the bank's business and operating model
Project Management of tactical solutions to remediate gaps and strategic solutions that optimize processes along with technology
Other Duties as assigned by the Director

Director, Regulatory & Government Affairs Resume Examples & Samples

Analyze, interpret and report on financial sector developments and policy initiatives; work cooperatively to develop RBC proposals and positions and prepare submissions to carry forward approved RBC positions
Work on cross-functional project teams to evaluate and provide insight on US and related financial sector policy developments and trends, including assessing potential impacts on RBC businesses
Support, assist, and lead, where appropriate, in the implementation of processes to define,communicate, and advocate for RBC public policy priorities, including direct oral advocacy and development of hearing testimony, comment letters, draft legislation, and other written materials
Support senior executives through briefings, analysis and recommendations in respect of RBC interactions with government officials and other stakeholders. Organize meetings, briefings, and other interactions with government officials, both in Washington, D.C. and at RBC offices, on subjects including financial services and other public policy matters. Make recommendations regarding appropriate activities of RBC USA Holdco Political Action Committee, including contribution recipients, contribution amounts, and PAC sponsorship of meetings and other events for appropriate RBC executives
Establish and maintain relationships with elected and non-elected government officials, financial sector policy makers, key industry opinion leaders and other stakeholders to articulate and advance RBC’s views and enhance RBC’s reputation as a credible voice on public policy issues
Work with representatives from business and/or functional units as well as with external sources as needed to analyse and assess implications of legislative and regulatory policies, and to develop appropriate responses
Represent RBC’s interests in industry consultations and trade association processes and at conferences and seminars on financial sector issues
Play key role in the development of unified and consistent positions on public policy priorities. Support business leaders in serving client needs and interests, including with respect to information, analysis, and advocacy of public policy positions that are also supported by RBC
Post-graduate degree
Eight or more years of relevant experience in federal financial services public policy arena
Prior experience in U.S. Congress and/or U.S. federal financial regulatory agency a plus. Some political experience (campaign volunteer, PAC administration) helpful but not necessary

Associate Director Regulatory CMC Resume Examples & Samples

Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations
Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls (10%)
Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs. (50%)
Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)
Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)

Associate Director Regulatory Initiatives Group Resume Examples & Samples

Strong derivatives knowledge, including experience in the financial markets, gained through trade floor experience preferably over 4 – 6 years
Previous experience with Operations and Project Management, managing a regulatory reporting project (such as Canadian reporting, DFA reporting, EMIR Reporting)
Experience in dealing with support groups
Attention to detail, implementation orientation
Ability to make progress on multiple projects at the same time
Comfortable dealing with ambiguity and an environment with few guidelines
Proven track record of meeting deliverables and managing within budgets an asset
Strong computer skills – particularly Excel and Access

Director, Regulatory Response Team Resume Examples & Samples

Lead Regulatory Response Activities
The role is specifically responsible for
Leading the development, implementation, maintenance and enhancement of the GRS Regulatory Response Framework in accordance with I&TS’ and IS Bank’s strategic and regulatory priorities
Response project management, coordination and support in relation to regulatory letters, audits, reviews, reports, information requests, on-site visits and any other regulatory communications requiring a response from IS Bank

Director, Regulatory Engagement & Policy Resume Examples & Samples

Leverage regulatory know-how and technical expertise and collaborate with internal and external subject-matter experts to identify, monitor and analyze salient developments from international, federal and state regulators, with a focus on banking and securities regulators
Lead preparation of internal written materials and presentations (including executive memos, briefing books, and talking points) to help ensure that business partners and clients understand key regulatory developments and business implications
Manage (with support from senior paralegal) tracking of regulatory developments of interest to the enterprise
Draft external communications (including position papers, issue briefs, and comment letters) and represent TIAA’s views with external stakeholders
Provide analytical support to senior members of the team on a wide variety of assignments
JD degree from an ABA accredited law school and member in good standing of state bar is required
Experience advising management teams on regulatory issues in the financial services industry is required; 3-7 years of experience is preferred
Experience drafting submissions to United States and international regulators is required; previous experience with submissions to financial regulators is preferred
Experience leading internal education and training programs related to financial services regulatory developments is required
Proven ability to analyze and distill complex regulatory proposals, leveraging internal and external subject-matter experts
Superlative writing and editing skills (executive communications experience preferred), adept at presenting complex regulatory topics in a simple, easy-to-understand manner. Skilled in tailoring writing to a variety of audiences, including regulatory submissions, executive briefings and media talking points. Extreme attention to detail
Strong professional presence and excellent interpersonal skills
Proven organizational/project management abilities
Proficiency in PowerPoint and Excel preferred (development of visual graphics through these programs a plus)
Excellent influencing skills, ability to drive consensus and build relationships with industry peers and regulators
©2015 Teachers Insurance and Annuity Association of America-College Retirement Equities Fund (TIAA-CREF), 730 Third Avenue, New York, NY 10017 C23921

Director, Regulatory, Research & Development Resume Examples & Samples

Identifies and communicates key responsibilities and practices to ensure the immediate team of direct reports promotes a successful attitude, confidence in leadership, and teamwork to achieve business results
Supports the implementation of Company programs, procedures, methods and practices to promote Starbucks key messages and achieve a competitive advantage
Assures compliance to quality and product safety standards from source of supply to consumer
Develops an integrated quality assurance program and budget covering beverage, food, merchandise, product distribution channels and retail facilities
Implements and manages the product safety and quality assurance program to ensure that product safety, quality and regulatory compliance standards are met for all beverage, food and merchandise items manufactured and sold in Starbucks retail stores
Manages quality assurance projects and supervises partners
Monitors the effectiveness and compliance of an ongoing training program on safe food handling and sanitation practices

Director Regulatory Program Manager Asset Management Resume Examples & Samples

Develop a plan reviewing current and future regulations that impact Asset Management
Working across the organization, ensure initiatives are funded and resourced appropriately
Interface with other CS regulatory functions, such as Legal, Compliance, Risk, and Public Policy to determine applicability of regulations on AM. Provide appropriate updates as required
Represent AM at IHC committee meetings, e.g. IHC CARMC, CCAR Challenge Sessions, Three Lines of Defense
Represent CS at meetings with regulators
Lead global extended project teams across multiple business lines
Manage multiple work streams within complex regulatory projects
Lead and manage governance and steering committees
Represent AM projects at global governance meetings, budget planning, and other project forums
Provide appropriate status communication to governance forums, stakeholders, and clients
Partner with Legal and Compliance to determine the business impact of proposed regulations
Accountable for the delivery of all phases of the project lifecycle
Develop implementation strategies and project plans
Develop and monitor budgets and resource plans
Conduct detailed process analysis, develop business requirements, and work with IT to translate these into functional specifications
Develop test strategies and execute functional and user acceptance testing
Develop control frameworks and integrate into existing compliance structures
Manage project issue and risks with timely escalation where appropriate
Build and leverage strong working relationships with key stakeholders and partners
Develop definitions and implement processes for reporting metrics

Senior Director, Regulatory Relations Resume Examples & Samples

Provide timely and accurate reporting of regulatory activity throughout SVB’s global footprint
Identify and report emerging regulatory issues or areas of scrutiny
Advise management and business teams of regulatory concerns or focus
Prepare management and business teams prior to their interactions with the regulators
Prepare management and business teams for examinations
Liaison for regulatory examinations
Coordinates and centralizes the flow of information between the various regulatory agencies and business teams
Trains SVB teams to communicate effectively with regulators
Facilitates ongoing meeting and regular interaction with the lead regulators
Ensures suitable accountability and proper remediation activity resulting from regulatory supervision
Prepares management and business teams for emerging regulatory issues and sensitivities

Associate Director Regulatory CMC EU Resume Examples & Samples

M.S. in a scientific discipline
8-10 years pharmaceutical industry experience with 4+ years direct EU CMC regulatory experience or PhD. in a scientific discipline with 6-8 years pharmaceutical industry experience and 4+ years direct EU CMC regulatory experience
Recent experience in the support of successful submissions and approval of submissions in the EU through the Centralized, Mutual Recognition, and National procedures and in post-license variations

Director, Regulatory Info Mgmt Resume Examples & Samples

Bachelor's degree in computer science, management information systems, or related field preferred or equivalent combination of education and experience
10+ years in the Pharmaceutical industry, 5+ years direct experience with Regulatory Affairs
Demonstrated leadership of significant cross-functional or global system and process implementation
Demonstrated information management and understanding of the drug development environment
Strong understanding of current and emerging technologies designed to enhance DSI’s business processes and practices
Experience and facility in working in a multicultural, multidisciplinary global environment
Demonstrated leadership in the management of staff and projects

Associate / Director, Regulatory CMC Resume Examples & Samples

Plan and coordinate regulatory submissions to support projects in development and commercial applications, including lifecycle management
Work closely with cross-functional teams to ensure short and long term objectives are achieved in a proactive and time efficient manner
May interface directly with Regulatory Agency personnel in order to expedite approval of pending application and to resolve regulatory matters
Write and author the CMC sections for IND, NDA, IMPD and other regulatory submissions based upon internal technical documents provided by Tech Operations or from vendor supplied documents
Identify key CMC content requirements in INDs and IMPDs for Phase 1 through Phase 3 studies for drug substances, excipients and drug products
Actively partner with development teams and counterparts to develop and execute US, EU and global regulatory CMC strategies and contingencies for assigned projects
Responsible for the development of CMC related documents for IND/IMPD/CTA in the CTD format and ensure they meet current regulatory standards, are of high quality, consistent, and complete
Establish product specific strategies to ensure successful development of CMC packages to support early development, registration and life cycle management
Accountable for reviewing and approving all CMC change control documents and disposition of proposed changes and scheduling submissions as necessary based on such changes
Develop timeline for responding to CMC related inquiries from global regulatory agencies to ensure issues are addressed in a timely manner
Schedule and track CMC project specific and operational activities relating to the regulatory department
Keep abreast of all pertinent regulations and guidance documents for pre and post approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications for necessary changes in planned CMC approaches
Participate in outside meetings and forums to ensure the latest thinking is applied to CMC strategies
Work effectively with regulatory colleagues specializing in liaison and operations to continuously improve regulatory systems, teamwork, and efficiency
Participate on due diligence teams as necessary
Bachelor’s degree in a scientific discipline required, advanced degree desired; typically the science degree should have a CMC focus
Minimum of 7 years biotechnology or pharmaceutical industry experience required
Minimum of 5 years in Regulatory CMC or Regulatory Compliance. Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
A solid understanding of US and EU regulations for human drugs/biologics. Experience and understanding of Japanese regulations a plus
Excellent technical writing skills of global submission documents (IND, IMPD, NDA, etc.)
Knowledge of global regulatory guidance documents and regulations with emphasis on the interrelationship between CMC and all other development. functions (for example, clinical supplies, qualification of impurities via toxicology testing, etc) as they relate to the overall global regulatory strategy
Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
Thorough knowledge of the drug development process, with a focus on IND and NDA processes. Experience in lifecycle is highly desirable
Demonstrated experience in preparing new IND and/or NDA submissions in e-CTD format
Results driven and team-orientated with the ability to influence outcomes as necessary
Excellent organizational, writing, communication and time management skills
Ability to work in a fast paced, ever evolving environment with a team focus and can-do attitude
Must be able to innovate, analyze and solve problems with minimal supervision and a keen attention to detail

Associate Director, Regulatory Liaison Resume Examples & Samples

Independently create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team
Independently create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e., mature) products
Support for Clinical Trial Applications (CTAs) in Phase I-III, Product, Registration and Launch (PR&L) filings and post filing activities
Critically review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues
Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label
Lead, collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety (GRACS), Merck Research Laboratories (MRL) and across Divisions with Global Human Health (GHH) and Merck Manufacturing Division (MMD) to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities
Lead business process space forums and other organizational initiatives and may represent RAI-HQ on cross-functional/cross-divisional teams
Act as the Global Regulatory Team (GRT) Lead for assigned products
Will have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc
At least 6 years of relevant experience in the pharmaceutical industry (4 years with advanced degree)
Must have excellent communication skills (both oral and written)
Good organizational skills with a proven ability to balance diverse activities for multiple projects
Flexibility and negotiating skills
Demonstrated Leadership skills
Strong scientific and analytical skills
Proactive and creative problem solver that generates options, makes effective and timely decisions and resolves conflicts

Director, Regulatory Intelligence Resume Examples & Samples

Lead the creation and implementation of KMS enhancements through project management plans that define the project scope, assumptions, risks, and overall project approaches including resource needs, high level timelines and communications
Identify key internal information (HA inspections, lessons learned, quality metrics), external information (industry conferences, various industry publications like Gold Sheet, Rx360, IPQ, PDS, ISPE), GMP policy and guidance documents changes (FDA, WHO, MHRA, and others), Warning letters, HA inspection trends and R&D GMP/GCP/GLP trends as sources of information to be analyzed in order to provide focused knowledge to improve current processes or be proactive in the development of required new ones as a result of changing GMP requirements
Lead discussions through System Expert Committee and customers to continually modify KMS based on business, industry changes, and customer requirements to assure value added to our customers and drive quality improvements
Review, assess, and communicate to quality organization the knowledge gathered from key internal and external sources to aid in the assessment and development of implementation plans within Mylan as required
Minimum of a Bachelor's degree, minimum of 7 years of relevant pharmaceutical compliance, quality and /or regulatory experience. (An advanced degree may substitute for some years of experience.) Active membership in pharmaceutical organizations such as ISPE, PDA or other working groups is an asset
Must possess excellent communication and negotiating skills. Ability to read and interpret comprehensive GMP regulations, guidance documents, policy changes and HA inspection observations and responses required. Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners. Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application. Must be adept at independent decision-making. Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes, and SharePoint/SHARP
Position reports to the Head of Global Quality Compliance. Position has direct supervisory responsibilities. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization
Ability to perform computations such as percentages, ratios, and rates, as well as perform statistical analysis. Ability to draw and interpret graphical data. Ability to understand pharmaceutical calculations is preferred
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic domestic and international travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements

Senior Director, Regulatory Intelligence Resume Examples & Samples

Stay current on developments in quality policy and practice globally, and educate the Mylan community on quality evolution to drive continuous improvement and compliance
Lead the creation and implementation of Knowledge Management Systems enhancements through project management plans that define the project scope, assumptions, risks, and overall project approaches including resource needs, high level timelines and communications
Develop publications to communicate key information and actions to the Mylan quality network and greater Mylan community
Develop a process for gap/feedback analysis by internal customers to drive continuous improvement
Attend seminars and other industry leading forums for self-development and information sharing across network
Share experiences across Mylan communities of practice, business units, and networks on innovative approaches in knowledge sharing
Responsible for measuring and delivering project outcomes successfully. Implement and/or adapt processes and metrics to ensure project goals and objectives are achieved. Set performance objectives and incorporate feedback from the team and organization for continuous improvement
Minimum of a Bachelor's degree, minimum of 10 years of relevant pharmaceutical compliance, quality and /or regulatory experience. (An advanced degree may substitute for some years of experience.) Active membership in pharmaceutical organizations such as ISPE, PDA or other working groups is an asset. However, a combination of experience and/or education will be taken into consideration
Must possess sound knowledge of applicable cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance (as necessary) based on the applicability of the regulations to the subject being evaluated. Must be familiar with all other GXP concepts and global regulations (FDA, MHRA, WHO etc.)
Must possess excellent communication and negotiating skills. Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners. Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application. Must be adept at independent decision-making. Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes, and SharePoint/SHARP
Ability to read and interpret comprehensive GMP regulations, guidance documents, policy changes and HA inspection observations and responses Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems
Periodic domestic and international travel is required

Associate Director, Regulatory Labeling Resume Examples & Samples

Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. (80%)
Mentors the junior staff members in labeling project and process management to build labeling expertise. (5%)
Prepares the submission ready labeling documents including the SPL and packaging artworks. Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate. (5%)

Director Regulatory Customer Strategy Resume Examples & Samples

Prior FDA Regulatory consulting/guidance experience with Product Landscape Analysis, Submissions, Survey, and Assessments, preferably for REMS programs
Ability to effectively communicate department objectives and contributions clearly with a proven record of gaining buy-in and support for initiatives from senior management/leaders
Strong problem solving skills with the ability to negotiate, arbitrate, resolve conflict and ambiguity
Experience in developing employees through coaching and counseling
MBA or MHA degree, preferred
Healthcare professional training & experience (RN, Pharm. D, PhD, MD), desirable

Director‚ Regulatory Consulting Resume Examples & Samples

As a Director within an expanding team, you will have responsibility for leading assignments while also working with the senior team in defining and developing strategy and long term business plan proposals for the business, with an emphasis on the delivery of services to clients. Being part of a specialist group, but within a truly global firm, means your personal impact will be instant but will be supported by an ambitious full service professional services firm
Responsibility for driving business development
Forming deep contacts in the industry and networking with the aim to grow the practice
Updating clients on regulatory change including running internal and external training courses and drafting articles for various publications

Director Regulatory Assurance Americas Resume Examples & Samples

Provide leadership and guidance to senior and executive management on regulatory strategies for expeditious submission and approval of new product registrations and for maintaining approvals of existing products. Provide regulatory guidance and support for developing new business models
Drive regulatory strategy and ensure regulatory plans are monitored; communicate progress and/or variances to regulatory and business leadership. Identify and communicate any risks from emerging technical data, changing internal objectives, and external threats. Develop strategies for mitigating regulatory risks
Direct the strategic and tactical efforts for Lonza active ingredients; ensure proactive support of chemistry defense activities for the LSI active ingredients portfolio. Provide guidance and direction for responding to product regulatory challenges. Ensure compliance with product regulations, while delivering efficient/responsive regulatory services. Strong commercial orientation for supporting both internal and external customers. Develop and maintain relationships with regulatory leaders of key customers
Direct strategy and tactics for national, supplemental and state product registration programs. Notifies product marketing initiatives of the requirements necessary for regulatory compliance
Manage and maintain relationships with key regulatory agency officials and with trade associations, standards setting organizations, and industry consortia. Proactively monitor opportunities and threats arising from new regulations and standards. Direct external regulatory consulting services and oversee advocacy to governmental and non-governmental organizations
Lead and manage the regulatory staff to ensure all projects are appropriately prioritized in line with direction from senior and executive business leaders, key goals are met on time, and commercial/customer support delivered. Direct regulatory personnel talent development, which includes succession and development planning, performance management, and recognition. Establish clear performance expectations for the team, aligned with business objectives
Develop and manage an annual department budget, both operational and capital spending
8+ years experience managing a diverse group of regulatory professionals., BS with 11 – 13 years experience or MS with 8 – 10 years experience. Technical and advanced degree preferred along with Regulatory Affairs leadership experience., Excellent networking skills with demonstrated experience representing an organization outwardly; naturally collaborative with a proven ability to partner and influence others at all levels of the organization., Experience with FIFRA, TSCA, and EPA regulations required; established relationships with EPA staff; Experience with FD&C Act and FDA regulations and established relationships with FDA staff preferred., Strong analytical, planning, and prioritization skills and ability to digest large, complex volumes of data and summarize for dissemination. Strong written and oral communication skills., Strong technical expertise and business acumen

Associate Director, Regulatory Reserach Resume Examples & Samples

Investigate and analyze regulatory precedence for FDA and EMA marketing application approvals across several therapeutic areas
Evaluate the totality of evidence used to support FDA and EMA marketing applications
Highlight and address, agency review comments, issues and trends that may be relevant to BioMarin development programs
Provide recommendations to project teams and senior management on regulatory pathways and development programs including clinical trial designs to support license marketing applications and applications for investigational products
Evaluate the impact of changes in the regulatory environment and regulatory trends
Keep senior management apprised of the implications of FDA and EMA regulatory decisions and proposals
The candidate must interact with regulatory research and other internal team members, senior management, regulatory affairs representatives, and potentially industry organizations
12+ years of experience in the healthcare industry, including at least 8 years of experience in Regulatory Affairs is required
The candidate must have substantial regulatory/clinical Phase I to Phase III development experience
Extensive research and analytical skills and attention to details are essential to thoroughly research and document the details of the development programs
Experience in identifying trends in regulatory research information
Experience in European Regulatory Affairs and procedures is beneficial
Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules is an essential requirement
Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders
Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) would be a plus
Excellent verbal, written and presentation skills

Director, Regulatory Research Resume Examples & Samples

Experience in the healthcare industry and extensive experience in Regulatory Affairs is required
Experience in identifying trends in regulatory research information
Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders
Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) would be a plus
Line Management

Director, Regulatory Policy & Intelligence Resume Examples & Samples

Ability to work in an intense, fast-paced, innovative work environment
Ability to work effectively as part of a global organization with internal executives and subject matter experts as well as with external stakeholders such as government officials and trade-association executives
Ability to lead across functions and drive to common goal
High degree of individual initiative/drive yet team affinity
Strong verbal/written skills
Extensive Regulatory / pharmaceutical experience
Bachelor’s degree in life sciences required; higher degree preferred
Deep knowledge and experience with regulatory affairs and regulations in the US
Successful NDA or BLA filing and approval experience; orphan/rare disease preferred
Demonstrable history of successfully serving in a leadership role either in, or working as a partner with, the FDA
Recognized expert in regulations, guidelines and precedents related to pharmaceutical development for small molecules or biologics
Skilled communicator and facilitator with the demonstrated ability to represent Vertex as the Company’s lead liaison in opening doors for communications; a bridge-builder
Deep understanding of the political environment and culture within the FDA and the ability to identify key players to be engaged
Experience interacting with senior FDA members at Divisional and policy levels; high level of credibility and respect

Director Regulatory & Safety Reporting Resume Examples & Samples

Bachelors degree or equivalent in Medicine or Science or significant experience within Drug Safety at a senior level
Able to evidence good practical knowledge of Regulatory Reporting Requirements
Previous experience of managing a global team of managers with strong leadership skills
Commercial awareness of RFPs preferred

Associate Director, Regulatory CMC Biologics Resume Examples & Samples

Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products. Be accountable for the delivery of all regulatory milestones through product development
Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks
Minimum 3 years regulatory CMC experience
Minimum 7 years of CMC development experience
Minimum of 3 years experience in the development of biologics products

Associate Director, Regulatory Research Resume Examples & Samples

Support senior Regulatory Researchers by compiling and analyzing data and metrics for reports on regulatory pathways and development programs to support US and EU marketing license applications
Identify the degree of clinical evidence supporting FDA and EMA marketing license applications across several therapeutic areas
Identify the issues raised during reviews and the approaches used to resolve the issues raised by health authorities
Perform searches across regulatory agency web sites, reviews, and using available databases to identify regulatory approval, labeling and clinical trial design precedence
Keep management apprised of FDA and EMA decisions and proposals, regulatory developments, and new regulatory trends
Generation of regulatory research reports detailing the scope of the search, findings, key messages and conclusions
Substancial experience in the healthcare industry, with a solid background of experience in Regulatory Affairs
Extensive research and analytical skills and attention-to-detail is essential to thoroughly research and document the details of the development programs
Strong collaborative skills, as this position requires close working relationships with both internal stakeholders

Senior Director, Regulatory Research Resume Examples & Samples

Experience in the orphan healthcare industry and extensive experience in Regulatory Affairs is required
The candidate must have substantial regulatory/clinical Phase I to Phase III development experience
Extensive research and analytical skills and attention to details are essential to thoroughly research and document the details of the development programs
Experience in European Regulatory Affairs and procedures is beneficial
Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules is an essential requirement
Clinical experience is essential
Strong due diligence experience
KOL Ad Board experience/ interactions

Director Regulatory Customer Strategy Programs Resume Examples & Samples

Ability to provide strong leadership and influence to matrixed, cross-functional teams in managing multiple projects with conflicting priorities and market imposed deadlines
Strong technical writing, verbal communication and presentation skills
Strong ability to adhere to standard methodologies and processes in a highly regulated environment
Healthcare professional training & experience (RN, Pharm. D, PhD), desirable

Director, Regulatory Advertising & Promotion Resume Examples & Samples

A minimum of a Bachelor’s degree is required, preferably in a health or science-related field. An advanced degree (PhD, Pharm D, JD, MBA, etc.) or Regulatory Advertising & Promotion experience is desirable
A minimum of 10 years of related experience is required with 8 years of experience at a Health Authority, pharmaceutical or biopharmaceutical industry is preferred
Experience as a People Manager or working in a matrix organization is required
This position is located in Horsham, PA and required up to 10% travel.Health Care Compliance

Director, Regulatory Strategist Resume Examples & Samples

Develop and lead Global Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement
Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans
Provide leadership to resolve critical regulatory project issues, bringing the appropriate regulatory experts together as needed to assist in the resolution
Establish sound regulatory advice/position on key development issues, and communicate same to Development Team Lead and other team stakeholders
Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources
Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies
Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters
Develop and approve the vendor contracts and relationships required to deliver regulatory documents and dossiers of high quality
Provide strategic regulatory input on the target product profile, CCDS, and country-specific label
Create an asset specific global HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions
Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors
Approval of regulatory documents
Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines
PhD, MD, PharmD with at least 10 years of relevant regulatory experience; other degrees will be considers with appropriate experience
Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration
Diverse experience in development and regulatory activities in support for product registration and maintenance, especially with outside partners/vendors
Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
Experience leading cross functional matrix teams
Demonstrated ability to break down complex, scientific issue and communicating regulatory implications
Proven success in negotiating regulatory objectives with HA

Executive Director, Regulatory Labeling Resume Examples & Samples

Leading cross-functional teams (LWG/ELB/SMT) in the development and maintenance of drug product labeling
Provides labeling strategies and guidance to facilitate development/maintenance of safe and commercially viable drug product labeling to facilitate best possible patient and company outcomes
Establishes required participants, accountabilities and timelines for labeling decisions, ensures stakeholder awareness of and adherence to, corporate labeling processes
Troubleshoots and solves any conflicts or issues on the critical path to reaching a labeling decision
Facilitates consensus among labeling teams and secures proper sign-off on labeling decisions
Solicits and ensures corporate approvals for the implementation of labeling changes are received and maintains record of labeling decisions and approvals (LPT), notifies appropriate corporate stakeholders of approved labeling changes and assures timely dissemination of information
Responsible for drafting, editing, proofing and creating final corporate approved product labeling documents in corporate labeling document management system (EPIC)
Provides Regulatory Submissions (link/virtual document) of final approved labeling documents (Word and Structured Product Labeling (SPL) formatted labels) for agency submission
Leads cross-functional team discussion on the process for implementation of FDA approved product labeling (US prescribing and patient information and Dear Health Care Provider (DHCP) Letters)
Enters editorial corrections of relevant labeling changes in the Bin and Corrigendum System, in collaboration with Global Labeling Operations (GLO). GLO utilizes information for Annual Report of Minor Changes
Supports corporate audits of product labeling processes and documents, provides requested materials, assists in interpretation of variation/deviations and highlights for GLOC discussion. Makes first pass assessment as to deviation/variation potential impact and required follow-up
Creates and maintains cumulative annotated labeling history documents for assigned products in corporate document management system (EPIC) Label History folder
Data entry and tracking of all labeling decisions/approvals into corporate Label Process Tracker (LPT); including tracking of labeling submissions to health authority; health authority decisions and notifications
Maintains external Label Process Tracker (LPT) logs related to deviations to product CDS, SOP 001170, and SOP 00691. Tracks and monitors PSRM Timeline Extensions for US RRR in SICMS
Ensures continuity in labeling lifecycle and stakeholder contribution from development Core Data Sheet (dCDS) to CDS to Regional Prescribing Information
Ensures that Core Data Sheets and regional labels provide essential information for the safe and effective use of the product(s) and are accurate and current
Develops and executes product labeling strategies that are aligned with global regulatory requirements/standards and corporate strategy
Collaborates with regional affiliates in the development and maintenance of global drug product labeling
Analyzes various regulatory and labeling alternatives for drug product labeling and recommends of alternatives to facilitate best possible patient and company outcomes
Maintains awareness of regulatory legislation pertaining to labeling and assesses and communicates its impact on the business and products of the company
Periodically reviews drug product RPI labeling for assigned products. Ensures CDS updates are implemented regionally in accordance with established corporate timelines and regulatory requirements / standards
Independently creates and maintains competitive labeling comparisons, proprietary regional labeling comparisons and precedent searches. Actively assesses impact of proposed labeling changes in relation to competitors
Contributes to improvements of new and current labeling processes to improve efficiency, productivity and quality, standards development, and metrics
Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs
Sponsors internal and external (cross-functional) special projects
Advocates and actively supports regulatory/safety compliance
Owns and ensures compliance with Global Labeling SOPs and BPs
Approves all drug labeling and escalates labeling issues at own discretion
Develops and implements Global Labeling strategies to proactively address changes in regulatory environment affecting labeling
Partners closely with TA leads to develop and manage regulatory labeling strategies to facilitate product development and global submissions
Ensures that agreed global labeling strategies are efficiently implemented during drug product development and life-cycle management
Ensures that global labeling strategies are maintained in-line with changing regulatory and business needs
Participates in the development of internal and external strategies to proactively influence legislation/guidelines with impact on labeling
Contributes to regulatory affairs process improvement though development of scalable and responsive SOPs and BPs for global product labeling
Accountable for disseminating and explaining corporate and departmental information to staff and ensuring understanding and adherence to changes
Contributes through strategic management of subordinate managers and direction of major discipline or operation within Amgen, even though does not directly supervise large numbers of staff

Director Regulatory Relations Resume Examples & Samples

Support the timely and successful remediation of identified issues, as needed
Contribute to the remediation plan development process
Build and oversee a strong, knowledgeable Regulatory Relations team, with consistent approach for managing our relationships across the US operating entities
Escalate issues to management, other stakeholders and relevant governance committees, as appropriate
Direct regulatory communications and deliverables
Establish proactive, productive relationships with all Santander US operating entities, Senior Management and other stakeholders
Bachelors degree; Masters degree desired
Minimum 10 years of bank regulatory management
Demonstrated Strong Relationship Building Ability
Demonstrated ability to operated successfully in a fast-paced, multi-faceted and dynamic environment
Excellent interpersonal, communications and leadership skills
Exemplary Leadership Skills
Regulatory Relations experience at large, complex financial services institution(s)

Director, Regulatory Risk Resume Examples & Samples

Provide technology compliance advisory services to capital markets institutions
Support clients with front office technology, in particular with Equities or Options trading platforms, compliance technology and regulatory reporting in broker dealer and SRO environment
Develop and execute go to market strategies related to regulatory reform initiatives, including trading and markets regulation
Lead and support proposal and business development activities by identifying new target clients, building business relationships with key executives, and developing and presenting proposals
Provide leadership and oversight to KPMG team members regarding deliverables, project plans, and performance
Serve as a leader in recruiting and retention efforts to develop the practice
Seven years of related work experience in technology compliance
Experience in managing projects and teams to successful outcomes
Ten years of experience in advisory services or project management or applicable industry experience
Progressive experience leading teams and managing projects and the ability to manage a multi-disciplinary team

Director, Regulatory Strategist Resume Examples & Samples

Participates in and supports business development initiatives in Asia Pacific
Interacts closely with clients to understand their needs with respect to drug development
Leads discussions with clients on regulatory strategies pertaining to Asia Pacific by mapping out the geographic regulatory landscape, and identifying key regulatory issues critical for successful execution of the strategies
Together with clients develop sound and implementable regulatory strategies for Asia Pacific countries
Anticipates and communicates with clients on significant regulatory developments in Asia Pacific
Enhance and further develop regulatory intelligence in Asia Pacific
Provides regulatory thought leadership in forums like conferences, seminars and industry discussion group

Clinical Director Regulatory Programs Resume Examples & Samples

Clinical experience required (Lab, Nursing, Pharmacy, etc.)
Bachelor Degree, Masters preferred
Meaningful Use or quality program(s) experience required, preferably within multi-hospital system setting
Minimum of five years’ experience in healthcare management, clinical leadership, or clinical information technology positions
Strong interpersonal skills - verbal, written and presentation skills
Strong leadership skills across diverse groups
Strong research skills – federal and state regulations
Possess the ability to effect change among various groups, especially as it relates to the use of clinical technology
Formal informatics training and/or experience preferred
Demonstrated involvement in large multi-faceted clinical IT projects

Director, Regulatory Compliance Strategy Resume Examples & Samples

Establish a national strategic vision in regulatory complaints, to include Legal 'Hot Topics', to ensure successful resolution and maintain 95%+ on-time responses
Partner with Operations Director in delivering a unified approach in strategic initiatives, solidifying support of peers and leadership across the enterprise
Conduct weekly and monthly assessments of National and Regional performance to ensure alignment to key performance indicators
Lead with innovation, seeking opportunities to enhance the customer experience beyond traditional intake and resolution practices
Ensures shared success across the enterprise by driving results with National, Divisional and Regional partners
Monitor and perform analysis in regulatory complaint trends, sharing with senior leadership at Corporate and Regional level
Acts proactively to assess and mitigate risk to the company, sharing potential liabilities with a focus on solutions
Experience with legal and regulatory compliance
Experience with setting and driving performance metrics and KPIs
Experience in leading quality assurance efforts
Understanding of current regulations in the cable industry
Excellent analytical, problem-solving, and decision-making skills
Willingness to support team to meet deadlines to regulatory agencies
Keen business process intuition, strong interpersonal skills, and a team-player approach
Proven ability to maintain composure in stressful situations
Generally requires 10 plus years of related experience in customer service, customer strategy, analytics, or metrics & reporting
Experience using and working with Tableau reporting platforms a plus
Understanding of customer service and regulatory industry trends
References required

Director Regulatory & Clinical Affairs Pcms Resume Examples & Samples

Master’s degree, preferably in a life-scientific discipline, and a minimum of 15 years of experience working in quality and regulatory affairs within a global medical device industry, of which 7 years were in a senior leadership role
Extensive knowledge of MDD, MedDev’s, FDA QSR’s, ISO 13485, and other for the market EMEA applicable regulations. Experience with Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation
Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access
A comprehensive understanding of the diverse worldwide medical device regulations, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner
Proven experience in understanding consequences of new and changing regulations to markets and business groups and effectively and pro-actively transferring this knowledge and understanding to all applicable stakeholders to ensure timely compliance with these regulations and guaranteeing continuous market access
An ability to successfully lead virtual teams of RACA professionals existing of both direct and functional reports in order to effectively and efficiently execute pre-market approval and post-market surveillance processes
Proven experience in successfully representing organizations in industry associations The experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams

Director, Regulatory & Strategic Analysis Resume Examples & Samples

Identify impacts of regulatory and legislative initiatives (regulated, competitive, environmental, structural) on corporate positions from a regional, state-specific and national perspective. Provide strategic decisions on regulatory and regulatory based legislative actions to be taken in state jurisdiction. Develop alternatives to the point where they are taken to executive management for final decision-making. Represent Xcel as a witness at legislative hearings as needed
Work directly with senior management to develop and promote regulatory and legislative policy positions. Maintain oversight of regulatory rulemaking activities and direct preparation of written and oral comments
Continuously interact with regulators, stakeholders and internal company experts to identify and proactively pursue results that reflect Xcel’s regulatory and legislative policies and strategies regarding matters such as development and cost recovery of utility infrastructure and other utility business
Advocate Xcel’s position with regulators and stakeholders in a variety of forums. Communicate (orally and in writing) regularly with executive management and internal experts to ensure awareness of the impact of strategies and positions on Xcel’s operations. Ensure, to the extent possible, consistency in policies and positions in each of Xcel’s state jurisdictions and the federal jurisdiction. Prepare, oversee the preparation of, and provide supporting testimony as required
Directs preparation of written comments, testimony, position papers and briefing material on regulatory and legislative policy matters. Serves as project manager for developing and implementing policy initiatives

Director, Regulatory Consulting Resume Examples & Samples

Experience as a conducting officer in the field of investment management oversight, legal, or risk are considered distinct advantages
Experience in a Management Company or within a company as a COO that has a business connected to AIFM is considered a significant asset
Dedicated experience and previous exposure to alternative investment strategies, namely Private Equity, Real Estate, Loans Origination/Restructuring, and Hedge Funds

Director, Regulatory / Quality Resume Examples & Samples

Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc
Provides counsel and manages the regulatory and quality assurance teams
Responsible for the establishment and execution of a process for the preparation of organized and scientifically valid applications and meets the company quality management process
Provide expertise in translating regulatory and standard requirements into practical, workable plans and guidance to the functional area that is impacted
Interacts with regulatory agencies at all levels, e.g. audits, product review
Develop strategic and tactical plans for national and international regulatory and quality management systems
Establish operational objectives, work plans, and delegates assignments to subordinate managers and staff
Plan, schedule and manage the work of the quality and regulatory departments
Document, implement and continuously improve Leica Biosystems’ Quality Systems and regulatory processes and activities
Manage the proper and timely preparation of national and international submissions in accordance with company goals and responsible for the associated follow up and reporting activities
10 plus years Quality/Regulatory management experience in a medical device environment
Demonstrated working knowledge of quality systems, national and international regulatory requirements, clinical studies management, and compliance programs
Proven ability to lead quality and regulatory teams to success
In depth Medical Device Quality Management System knowledge and experience, including ISO 13485
Direct experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies required
Excellent interpersonal, project management and motivational skills
Prior experience with regulatory, submissions/clinical studies, compliance program and quality systems development, implementation, and management
Experience with worldwide regulatory submissions in the area of in vitro diagnostics (IVD) or medical devices (Class I and II)
Experience with Class III medical devices preferred but not required

Director Regulatory Resume Examples & Samples

Regulatory Asset Quality Liaison: Partner with Regulatory Affairs, Credit Administration Leadership, and Credit Approval Leadership to administer regulatory exams involving Credit Approval and Credit Administration. Duties to include: collection and organization of entry level items; sample analysis and distribution; assist in OnBase training and support; Relationship Management/Senior Management coordination; escalating potential issues to senior management; qualifying and validating all potential recommendations or findings; clearing technical exceptions; discussing potential loan downgrades; and drafting, implementing, and tracking all corrective action items
Internal Audit Liaison: Partner with Credit Administration Leadership, and Credit Approval Leadership to administer Internal Audit exams involving Credit Approval and Credit Administration. Duties to include a subset of those listed for the Regulatory Asset Quality Liaison
Enterprise Risk Management (“ERM”) Liaison / External Loan Review: Responsible for identifying and escalating unusual risk trends to others in both the first and second lines of defense, as well as assisting the first line of defense risk management activities. Qualify all findings and recommendations made by ERM and extensions of ERM including external loan review. Also responsible for facilitating ERM deliverables on behalf of Credit Administration. Examples to include coordination of data submissions and/or implementation of template and/or process and procedure amendments
Loan Policy: Maintain Credit Risk Management Policy and Lending Standards (together, “Loan Policy”). Duties include: partnering with Credit Administration Leadership, Credit Approval Leadership, and related parties on amendments to Loan Policy, maintaining related change logs, and managing the approval submission process (Board: Credit Risk Management Policy; CERM and/or the Board: Lending Standards)
Allowance for Loan Loss: Partner with Credit Administration (Head of Credit Administration; Portfolio Analytics), Chief Financial Officer, and Chief Accounting Officer on the additional development and documentation (quarterly packages; Model Risk Management documentation; and related policies) for the ALL. Including implementation of CECL as necessary
Targeted Loan Review: Partner with Director of Loan Monitoring, ELC, Head of Credit Administration, and Chief Credit Officer in periodic targeted loan reviews. Duties to include partnering in: determination of target RMs/BBs/portfolios, administration of review process, production of review summary/tracker, and review follow-up
Provide input for enhancements to: risk grading and policy exception options, definitions, and tracking; flag reporting inputs and templates; underwriting and systems input templates; originations and monitoring processes/systems; internal reporting, etc
Participate in ad hoc Credit Projects/Research
Must have a Bachelor’s Degree. Graduate Degree or related studies preferred
Must have extensive loan portfolio review experience, including ability to qualify and if necessary, challenge recommendations or findings
Must have experience interfacing with banking regulators
Completion of a formal credit training program preferred
Must have a minimum of 10+ years of prior banking, credit, and/or banking regulation experience
Must have significant knowledge of SFR, HELOC, CRE/MF, Construction, Business Banking, Other Secured and Unsecured loan products
Must possess micro and macro level credit knowledge –loan level and portfolio level comprehension
Must possess direct experience with / understanding of FRB geographic markets
Strong understanding of/interest in Allowance for Loan Loss modeling (risk rating, reserve setting, loss rate analysis, etc.)
Strong communication and interpersonal skills, including experience working with all levels of management across all bank departments. Strong project, process, and time management skills, including the ability to manage multiple tasks in a fast paced environment
Strong analytical abilities and technical writing skills
High have a concern for quality and attention to detail
Must be presentable - client facing and sales skills preferred

Director, Regulatory Projects Resume Examples & Samples

Clearly articulate business outcomes, which include: the identification of desired business outcomes and underlying assumptions; business and technology costs, risks and benefits; necessary prerequisite initiatives; required supporting actions and intermediary outcomes. Other accountabilities include: determination of organizational and financial feasibility of the project; assisting with the completion of the business case; identification of required resources; identification of interdependencies and pre-requisites and preparation of an appropriate governance and risk management plan
Define and quantify the solution. This includes ensuring at the project outset
Proper consideration of business, regulatory and operational deliverables as well as technical standards
Definition of development activities at sufficient detail levels
Articulation of the risk-based testing plan and scope; and
Description of business, regulatory deliverables, operational impacts, user communication, training and implementation plans
This must be formally documented, as per standards, costed and represented in the business case, project plan and tools (i.e. Microsoft Project)
Leadership and management of the delivery process as documented in the Project Delivery Framework while ensuring the documentation and archiving of project activities, deliverables, tools and findings for future projects
Leading the Project Team and maintaining the momentum of the Project against background of changing and occasionally conflicting priorities. This includes a balanced and timely approach to problem resolution and escalation, where required, to higher levels of management
Ongoing communication of project status, completing the Project Status Reports and escalating issues to the stakeholders, Sponsor(s), and Senior Executive (to the SVP and up) in IOSS as well as business lines and operational groups, as required
Leading and mentoring a team of Senior Managers (L8), Manager (L7) Project Control Officers (L7) and Contractors
5-10 years of experience in the financial services industry, managing large complex projects, that have significant Capital Markets, Regulatory, IT and operational components
Working familiarity with project management methodologies
PMP Designation an asset
Spanish fluency is a an asset

Director Regulatory Consulting Manager Resume Examples & Samples

Oversee project structure, approach and process
Manage overall quality and timeliness of project delivery
Lead and manage presentations for management
Bring regulatory and financial services content expertise and drive resolution of complex issues
Manage and motivate resources at all levels
10+ years of experience with a Regulator, in a regulatory-related role in a Corporate and investment bank, or leading large transversal projects within a Regulatory Consulting practice
Strong executive presence and comfort working with senior executives
Manages one or two projects independently
Writes sharp and straight-to-the-point management summaries
Sets high quality standards

Director, Regulatory Business Liaison Resume Examples & Samples

Occasional travel is required given the scope of role
Role interfaces with operational risk management and with assigned senior business unit management
Physical Demands/Work Environment: Very good working conditions. Little or no physical demands. Minimal handling of light materials. The physical demands/work environment described above are representative of those that must be met by an employee to successfully perform the essential duties of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties
FINRA Series 7, 24 (or 9 & 10) Insurance Licenses required. 90 day contingency may be granted solely at management's discretion
Broad scope of knowledge of financial services business including Wealth Management, products, operations, systems and organization

Senior Director, Regulatory Research Resume Examples & Samples

12 plus years of experience in the healthcare industry, including at least 8 years of experience in Regulatory Affairs are required
The candidate must have substantial regulatory/clinical Phase I to Phase III development experience, and have worked on a minimum of at least two marketing application approvals
Extensive research, analytical skills and attention-to-details are essential to lead research projects and critique reports
Extensive experience identifying trends in regulatory research findings
Demonstration of strong critical thinking abilities is essential
Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules
Experience in European Regulatory Affairs and procedures would be beneficial
Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) essential
Orphan Drug experience is also highly desirable

Director Regulatory Compliance Control Room-personal Account Dealings Resume Examples & Samples

Provide direction and support for the responsibilities and functions of the Global Control Room team
Act as the key contact in the Global Control Room in relation to IT systems, restrictions and personal account dealing
Develop and refine Global Control Room related policies and procedures in the key areas of coverage
Attend industry discussions/roundtables pertaining to Global Control Room issues
Provide clear guidance to members of the Global Control Room as well as the business and function lines
Other ad hoc project work as agreed with the Head of Control Room
Previous experience of managing conflicts within a global/commercial banking environment
Previous compliance and/or regulatory experience, preferably across a number of different business lines
Excellent communication skills, as the role requires constant communication with other individuals and teams within the HSBC Group
An excellent understanding of the regulatory environment and expectations, regulator rules and guidance together with other relevant regulations, codes of practice and HSBC Group Standards
Ability to make and support decisions with sound reasoning. Ability to clearly articulate business and regulatory implications of analysis and findings
High standard of written documentation
Ability to work with minimal supervision and on multiple tasks simultaneously and uses own initiative to resolve issues
Must have a flexible approach to work and working hours

Director, Regulatory Consulting Resume Examples & Samples

Responsibility for driving business and product development
Overseeing service delivery, client interface, practice management
Project managing teams on complex and technical consulting projects across a range of clients
Providing ad hoc regulatory advice and solutions in your subject matter
Updating clients and internal teams on regulatory change including running internal and external training courses and drafting articles for various publications
Continuous monitoring of regulatory change and ensuring the team’s knowledge is kept up to date

Director Regulatory Policy & Intelligence Resume Examples & Samples

Actively contribute to Regulatory Affairs organization to achieve business objectives
Lead a team of regulatory intelligence professionals to gather, analyze, and communicate timely and relevant regulatory information, globally
Monitor and assess the global regulatory environment to anticipate and communicate regulatory trends through an understanding of regulatory guidelines, regulations, and laws that may impact Bayer’s products or regulatory business processes
Collaborate with regional regulatory policy, therapeutic areas, and other functions to stay abreast of changes in the global regulatory environment, and to quickly review, analyze, and summarize regulatory developments
Govern the process for assessing draft legislation, regulations, and regulatory guidelines to recommend development of Bayer-specific positions and technical comments
Design and develop Technology-enabled analysis and reporting tools to deliver actionable regulatory insights, including creation of a regulatory intelligence dashboard, trend analysis, and other data visualization tools
Collaborate with regulatory affairs leadership and IT business partners to translate regulatory objectives into an information management and regulatory intelligence strategy
Effectively communicate (verbally, written, published, unpublished, etc.) regulatory intelligence to a broad, diverse, and global audience using traditional, and non-traditional communication tools
Bachelor’s degree with ten (10) plus years of relevant experience in a regulated environment
A working understanding of medical product regulation
Superior communication skills, both verbal and written
High customer focus
Demonstrates ability to attract, develop, and retain talent
Effectively lead and manage people across multiple geographic locations
Promotes a culture of teamwork, customer focus, and innovative thinking
Data-oriented personality with strong analytical and strategic mindset
Good in dealing with ambiguity
Basic understanding of machine learning techniques
Embraces change and should possess the ability to effectively work in an international and multicultural environment
Up to 25% domestic and international travel
Degree in life sciences, computer sciences, or health-related discipline
An advanced degree (J.D., Pharm.D., M.D. Ph.D.)
Experience with common data science tools and data visualization tools

Regional Director, Regulatory & Accreditation Resume Examples & Samples

Registered Nurse (RN), BSN degree preferred, with experience in regulatory requirements and accreditation standards, performance improvement as applicable in other related areas of responsibility
Knowledge of TJC and other regulatory standards
Knowledge of CMS CoP Conditions of Participation and other federal requirements
Knowledge of principles of quality improvement
Relevant clinical experience

Director, Regulatory Enforcement & Compliance Resume Examples & Samples

A minimum of eight years of experience in either Compliance or Internal Audit in a hospital, physician or healthcare consulting role; relevant experience with a Big Four accounting firm and/or experience within an Internal Audit department of a large multinational company is preferred
Bachelor’s degree in a related field from an accredited college/university and advanced degree (i.e., MHA) or certification (i.e. RHIA, RHIT, CCS) is preferred
Exceptionally-high professional and personal standards, unquestioned integrity, and business ethics to speak on significant issues and provide recommendations to drive change when necessary

Associate Director, Regulatory CMC, Biologics Resume Examples & Samples

Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings
Lead the preparation and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions
Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required
Responsible for the management of CMC activities related to specific developmental or commercial compounds
Responsible for the regulatory evaluation of CMC change controls
Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams
Take a leadership role in the CMC development/commercial teams
Maintain knowledge of global regulatory environment, regulations and procedures
BS/BA degree in Scientific Discipline (Masters or higher preferred) with a minimum of 7 years in the pharmaceutical industry, and a minimum of 5 years CMC regulatory (biologics preferred) experience
Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications
Thorough knowledge of FDA, EMEA and ICH guidelines
Knowledge of rest of world pre- and post-approval guidelines
Have a solution-oriented approach to problem solving
Expertise in the biologic drug development process and post approval activities
Ability to work on complex projects and within cross-functional teams
Prior supervisor or project management experience
Experience with global CMC regulations for biological compounds

Executive Director Regulatory Management Resume Examples & Samples

Directs a team responsible for improving the generating asset's P and L, operations monitoring, development and assessment of value-added ideas to optimize asset performance and increase profitability
Plans activities to ensure adherence to budget and operational objectives
Participates in business planning process for future development and growth and develops business opportunities to increase growth
Assists in the creation of shareholder value by performing financial and regulatory analyses, reviewing acquisition opportunities, and building relationships with regional and federal regulators
Maintains close working relationships with partners, customers and stakeholders
Directs or assists with value-added projects such as supporting regional leadership in the development of strategic plans, mergers and acquisitions, project development, asset optimization, restructurings and building relationships with off-takers, landowners, and state and local regulators
Experience:12+ years
Supervisor/Management Experience:5+ years
Master's - Business Administration

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