Senior Manager, Regulatory Resume Samples

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J Leffler

Jamarcus

Leffler

1825 Streich Bridge

Dallas

+1 (555) 221 9346

1825 Streich Bridge

Dallas

Phone

p +1 (555) 221 9346

Experience Experience

Dallas, TX

Senior Manager, Regulatory

Dallas, TX

Considine, Satterfield and Mayer

Dallas, TX

Senior Manager, Regulatory

Establishes processes and plans for performance monitoring and making recommendations
Ensure effective roll out of policies and procedures. Develop related training program and materials for workforce and contractors
Develops scope of work and supervises consultants in conducting assessments in accordance with Hess standards and accepted industry practices
Active participation in asset stakeholder manager strategy and execution
Provide regulatory expertise and support to business partners
Frontline advice to business partners regarding the development and implementation of Projects
Network with regulatory practitioners across the business, including the Houston Environment & Regulatory team, Legal and Government Affairs

Detroit, MI

Senior Manager, Regulatory Strategy

Detroit, MI

Shields Group

Detroit, MI

Senior Manager, Regulatory Strategy

Implement and lead select regulatory change in partnership with Technologies, Servicing, and Marketing
Coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change activities
Provide in-depth reviews of protocols, reports, presentations, and other documents
Assess how the business can implement Regulatory change into Amex processes, products, and systems in partnership with GCO, Compliance, Servicing, Risk Management, and Technologies
EMEA Senior Leadership Point of Contact: Act as primary interface to EMEA senior leadership team across all Regulatory Management initiatives
Provide leadership updates on project progress and risks
Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios

present

Chicago, IL

Senior Manager, Regulatory Promotions

Chicago, IL

Bednar Inc

present

Chicago, IL

Senior Manager, Regulatory Promotions

present

Supports strategic planning, development, workflow modifications, and updating operations guidelines and SOP's
Ensure that projects are completed on schedule following established procedures and timelines
Track and report performance metrics
Demonstrated excellence in project management and effectively managing multiple projects/priorities
Participate in implementation of relevant software systems related to Materials Review and perform User Acceptance Testing
Monitor daily operations and adherence to SOP's
Ensure consistency across functions for coordination of submissions, categorizing review types and prioritizing materials for review

Education Education

Bachelor’s Degree in Business

East Carolina University

Bachelor’s Degree in Business

Skills Skills

Strong knowledge of the GCP marketing and sales organization
Strong ability to understand process and/or operations management
Proven ability to adjust quickly to shifting priorities, multiple demands, ambiguity, and rapid change
Strong collaboration skills and demonstrated ability to network globally
Strong communication skills combined with an ability to interact effectively with senior leaders and business partners
Innovative thinking in designing and developing solutions against complex issues
Proven experience building and leveraging relationships to drive towards shared outcomes for our customers (i.e. Card Members, clients, partners)
Outstanding project management and organizational skills
This position will be located in the UK

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15 Senior Manager, Regulatory resume templates

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Senior Manager, Regulatory Capital Analytics Resume Examples & Samples

Undergraduate degree in related discipline: business / finance / economics etc
Analytical designation in related field an asset - FRM / PRM / CFA / etc
5 years business experience at a financial institution, primarily in credit risk management (financial analysis and / or assessment and / or credit risk modeling
Knowledge of Basel II and Basel III, in particular Standardized and IRB/AIRB Approaches for Credit Risk, and OSFI’s Capital Adequacy Requirements (CAR) Guideline A-1 and Implementation Notes for IRB Institution
Thorough understanding of BCAR and underlying principals including parameter impacts on capita
Thorough understanding of Pillar 3 requirements
Knowledge of risk management policies and practice
Strong quantitative skill
Excellent analytical skill
Excellent communication skills both written and ora
Knowledge of SAS and SQL would be beneficial, though no hands on programming would be require
Excellent working knowledge of Microsoft Office software (Excel, Word, PowerPoint)
Excellent Microsoft Office software (Excel, Access, Power Point and Word) skill

Financial Crime Senior Manager Regulatory Advisory Resume Examples & Samples

Financial Crime / AML and / or sanctions work experience/ professional qualification preferred
Consulting experience preferred
Strong academic background, ideally to a degree level or equivalent
Focus on one or more of the following areas: Wholesale Banking, Retail Banking, Investment Management, General Insurance
Leadership, project management and teamwork skills for delivery of financial crime engagements
Strong stakeholder management and communication skills for report writing and client presentations
LI-MANUAL-POST-JOB*

Senior Manager Regulatory Investigations & Client Complaint Resolution Resume Examples & Samples

Ensuring that client complaints are appropriately addressed, thereby improving the client experience and mitigating downstream risk
Managing the regulatory investigations involving TD Waterhouse Canada Inc. and Private Investment Advice - including implementing strategy for resolution
Providing advice and guidance to senior business leaders on complaints and investigations
Acting as a key liaison with provincial securities regulators and IIROC staff on behalf of the subject businesses
Providing reporting and education to key business partners on areas of risk and best practices
Acting as the point person with the OBSI in negotiating client compensation recommendations

Senior Manager Regulatory Development Resume Examples & Samples

Manages a centralized regulatory monitoring and change management process to support Legal in monitoring and communicating new legislation to mitigate legislative and compliance risk for one or more of the following global lines of business or functional area (including, but not limited to)
Global Banking and Markets (GBM)
Retail Bank & Wealth Management (RBWM)
Commercial Bank (CMB)
Financial Crimes Topics (including AML, OFAC and Anti-Bribery)
Sets priorities and makes day-to-day decisions independently. Escalates matters to senior management as needed
Minimum of eight years progressive legal, audit, compliance, financial services operations, and/or regulatory experience or equivalent
Bachelor’s or advanced degree in business, finance, accounting, related field or equivalent experience
Strong interpersonal, organizational, communications, analytical, and project management skills, with the ability to establish productive relationships with a wide range of internal and external stakeholders
Thorough knowledge of products, services, operations, and systems and extensive dealing with laws, regulations and regulatory agencies related to assigned areas

Senior Manager, Regulatory Harmonization Resume Examples & Samples

Analyze, provide advice, and develop strategies on proposed global food standards and potential trade issues relevant to foods and beverages (e.g., Codex, WTO, WHO, FAO)
Prepare and advocate company positions on global food standards to internal and external stakeholders by representing the Company at trade organizations and global organizations such as the Codex Alimentarius Commission
Identify opportunities for regulatory harmonization in collaboration with the Scientific & Regulatory Affairs network and manage such projects
Provide guidance on regulatory issues to internal clients and help develop innovative solutions
Guide and assist in preparing regulatory submissions to global organizations and other regulatory authorities
Project Management: Ability to manage projects to ensure successful delivery (on time, within budget, meeting agreed upon success criteria) to establish clear goals and accountabilities. Also includes the ability to develop project plans, allocate resources, identify potential issues/risks and develop contingency plans
Technical communications: Advises and educates colleagues by disseminating key facts and presenting complex information in a concise and easy-to-understand manner. Uses technical and business expertise to explain difficult concepts to technical and non-technical audiences, tailoring communications to meet diverse needs (e.g., other functions, management, external parties)
Regulatory Advocacy: Ability to write and advocate regulatory positions in a compelling manner and interact with government officials and other stakeholders at an international setting to promote and explain the views of the beverage industry in an appropriate manner
Regulatory Knowledge: General knowledge of the regulatory landscape (e.g., regulations, issues) that may affect the beverage or food industry. This includes recognition and appreciation of differences in the regulatory framework of different countries as well as some knowledge of the major regulatory issues facing the food and beverage industry
Food Law: Knowledge of food law as it applies to products, their ingredients and labeling. This includes knowledge of required/allowed levels and restrictions for ingredients or knowledge of where this information exists and how to access it. This may also include knowledge of whether an ingredient and labeling meets country level requirements
Legal Requirements: Knowledge of the legal requirements and the actions required to maximize company standing with regulatory agencies
Ingredients: Knowledge of key ingredients used in production of concentrates and beverage bases (e.g., caramel, citric acid, benzoate, juice, phosphoric acid)
Basic Product Development: Knowledge of the product development process and the ability to contribute expertise in customs, hazardous transportation, worker safety and labelling
Basic Nutrition: Knowledge of basic nutrition concepts and definitions involved in basic nutritional labeling
Technical and Ingredient Policies: Expert level knowledge of Company policies affecting ingredients, product composition, labels and/or technical claims
Consulting: Ability to provide timely, specific information, guidance and recommendations to help groups, managers and others make informed committed decisions that lead to sustainable impact
10-15 years of experience in food industry, government or related industry in similar roles

Senior Manager Regulatory Risk Services Resume Examples & Samples

As the Senior Manager, IIROC Regulatory Support be the IIROC BM for the designated CIBC ISI IIROC-registered retail branches. As part of this accountability, the Senior Manager, IIROC Regulatory Support is the person who is registered with IIROC as being responsible for the primary level of supervision of all activities within the branch including, but not limited to
Ensuring that proper registration is held by Advisors,
The oversight of account activity,
The assessment of advice given to clients; and
The review of incoming / outgoing correspondence
As the Senior Manager, IIROC Regulatory Support, be responsible for helping ensure that the management of client business is within the bounds of both regulatory and ethical conduct, consistent with just and equitable principles of trade and it is not detrimental to the interests of the securities industry or CIBC. This registered person must advise senior sales management and CIBC Wealth Management Compliance of any significant issues
Conduct periodic visits to assigned locations and complete the following activities
Periodically review a % of new accounts and existing accounts for documentation completeness
Fix administration file deficiencies
Manage various reports such as returned mail audit reports,
Review of quarterly branch profile report
Review of branch signage, brochures and business cards
Complete the following activities as per documented procedures
Complete client file reviews
Handle CRT notifications and follow up with registrants to ensure that issues are resolved
Manage all client complaints to resolution including reporting, documentation, filing of loss reports and compensation (if appropriate)
Follow up on debit balances with registrants to ensure that balances are covered
Manage the IIROC registration process for all new registrants
Submit all material changes / notices of termination within established timelines
Manage the ISI mail delegation letter and ensure that a process is in place at all designated branches for independent review of incoming mail for all registrants
Manage the Items Requiring Attention Report and follow up with registrants until the item is resolved
Submit PRO account notification
Ensure that all required procedures are followed to relocate an ISI Advisor and if the Advisor is transferred to an external designated branch, liaise with the appropriate Field IIROC BM to ensure that the transition occurs following appropriate procedures
Complete the RR Code Verification
As appropriate, complete the annual branch/sub branch review
Manage, as appropriate transitions in/out from CIBC Securities Inc to Imperial Investor Services
As the Senior Manager, supervise a team of RSOs. Provide leadership, direction, coaching, guidance and training to employees
Ensure optimum capability levels are developed and maintained
Provide specialized guidance to the team to enable them to address more difficult and complex related compliance issues with diverse client group (e.g. Financial Advisors, Branch Managers, etc.)
Ensure team is fully resourced and effective and professional orientation sessions are conducted with each team member
Provide regular formal and informal feedback
Ensure Individual Performance Scorecards and Individual Development Plans (IDPs) are in place for all direct reports to
Communicate performance goals and expectations,
Identify employee development needs, and
Manage and address performance related issues as required
Working with Branch Managers in your geographical location, determine priorities and establish plans to ensure client needs are met and resources are optimized
Ensure client groups are well informed of the team mandate, roles and responsibilities
Act as a champion for Imperial Service IIROC and Financial Planning compliance, consult with client group to ensure Regulatory Risk Services provided meet client needs and are in accordance with established service level agreements, procedures and policies
Act as the information source for IIROC compliance. Maintain "currency" in IIROC and financial planning compliance and regulatory requirements, practices, principles and technologies. Provide advice and direction on issues including existing and impending policies and relevant regulatory requirements. Ensure team is informed and capable of representing IIROC compliance. Educate client groups regarding internal and external developments related to IIROC compliance and financial advice. Communicate compliance-related information and manage/organize the delivery of compliance related learning delivered by team to client groups, their leaders and employees that have compliance responsibilities
Manage a budget and assigned resources to meet business objectives
Provide leadership and effective management of business unit staff to influence employee commitment to the organization, to the team, and to their job by
Building team and individual capabilities by providing development opportunities such as job shadowing, special projects, and training
Managing performance by providing fair and accurate formal and informal feedback, identifying and removing obstacles to performance and by explaining how performance expectations align with business priorities
Creating a positive work environment and being an effective role model by championing CIBC’s mission, vision and values
Ensuring compliance with policies, standards, guidelines and controls by applying the policies and controls fairly and consistently so employees understand what to expect, and
Hiring the right people in the right jobs to align individual capabilities with job requirements and business unit goals

Senior Manager Regulatory Capital Rdarr Project Lead Resume Examples & Samples

Document and establish characteristics requirements and operational process of each critical risk report (e.g. purpose, scope, recipients, frequency, high level content, limitations, emerging risk concentrations, and relationship with risk limits/appetite/tolerance)
Prepare an inventory of material manual processes (in context of risk exposure) and desktop applications documented and established.Compensating controls identified, updated/documented as appropriate, and established
Source systems and data lineage documented at appropriate level, from source to report, and established
Standards and procedures on data errors and data integrity weaknesses documented and established
Inventory of validation rules documented and established, including, at a minimum, explanations of conventions describing mathematical or logical relationships to be verified through validations or checks
Inventory of manual processes documented and established along with commentary regarding the plan to automate each item or rationale indicating why automation doesn’t fit into the strategic principles (i.e. resources better deployed elsewhere)
Risk data aggregation processes documented and established including explanations of automated processes and manual workarounds, a description of their criticality to the accuracy of risk data aggregation, and proposed actions to reduce the impact
Ensure that accuracy and precision requirements are defined to apply at a granular level so that they can be sustained through to aggregation
Report accuracy measures, metrics and thresholds documented and established for normal and stress/crisis situations
Significant experience with financial processes documentation, workflows, etc. Experience with regulatory reporting processes and systems would be a plus
Superior communication skills both oral and written
Working understanding of the Basel III Framework rules for large internationally active banks and OSFI’s Capital Adequacy Guidelines
Preferred 5+ years experience in the Finance area of a major financial institution including knowledge of regulatory reporting systems and processes will be a plus
Self motivated individual with excellent organizational and time management. Strong Communication and interpersonal skills, as the incumbent will interface on a frequent basis, with IT&S and other stakeholders

Senior Manager Regulatory Relationship Management Resume Examples & Samples

Provide support for the U.S. oversight of regulatory relations to ensure effective monitoring of exam activities and to identify and escalate issues to management
Collaborate with U.S. Legal and Compliance to manage a framework to identify, assess, control, and monitor regulatory communication across the U.S. Operations
Create and assist in controlling the process to respond to regulator requests ensuing quality control
Create and control a process to monitor the full lifecycle of identified regulatory issues ensuring that concerns are communicated, assigned responsibility, and tracked to resolution
Maintain an organized, centralized and easy to access repository where documents are stored and previous examination memos and reports are archived
Collaborate with Operational Risk to ensure new products and services are assessed and business practices are understood
Collaborate with U.S. Businesses and support groups to establish Key Risk Indicators at the Enterprise and RCA Level. Ensure appropriate KRI owners are identified and provide timely information
Prepare and maintain policies surrounding regulatory interaction and examination management
Monitor and analyze regulatory developments and help to determine which areas of the bank may be affected by new regulatory initiatives
Participate in the development and delivery of specialized internal training on the regulatory exam process and protocol
Coordinate with regulatory and compliance counterparts globally to share best practices and methodologies to maintain a competitive advantage for the bank and meet regulatory requirements

Senior Manager Regulatory Projects Resume Examples & Samples

A thorough knowledge of the regulatory reporting requirements of all countries throughout the International Division
A working knowledge of the automated systems in use throughout the International Division
Proven analytical skills to enable the incumbent to develop Regulatory Reporting processes and applications, and manage the implementation thereof

Senior Manager, Regulatory Risk & Compliance Resume Examples & Samples

Strong understanding of the financial services industry, relevant regulators (e.g. ASIC and APRA), and current and proposed financial services regulatory and legislative requirements
Ability to constructively challenge, consult and advise, whilst maintaining excellent relationships and the respect of senior executives
Experience in leading and developing people to deliver on operational goals, and a track record in maintaining a high performing team
Proven customer service orientation

Senior Manager, Regulatory Resume Examples & Samples

Provide regulatory expertise and support to business partners
Maintain current knowledge of regulations, leading practices, and technology for maintaining compliance
Understands pertinent regulatory requirements and aspects associated with the design and development of plans to minimize or mitigate impact and to provide appropriate assurance
Develops scope of work and supervises consultants in conducting assessments in accordance with Hess standards and accepted industry practices
Establishes processes and plans for performance monitoring and making recommendations
Maintain and update Policy, Standards, Procedures and Guidance for regulatory compliance
Ensure effective roll out of policies and procedures. Develop related training program and materials for workforce and contractors
Network with regulatory practitioners across the business, including the Houston Environment & Regulatory team, Legal and Government Affairs
Maintain the existing Compliance Asset Register with regulatory changes
Other special projects, such as the Regulatory Compliance Execution software implementation
10-15 years’ experience in oil and gas industry
More than 10 years’ experience in a regulatory and/or EHS management role in the upstream oil and gas industry
Operational background for Oil & Gas operation
Knowledge of EHS&SR Management Systems highly desirable
Travel within North Dakota required

Senior Manager, Regulatory CMC Resume Examples & Samples

Formulate CMC regulatory strategy for complex post marketing submissions and escalate potential regulatory challenges
Assess change controls and identify supportive data requirements while ensuring compliance with global regulatory CMC requirements
Serve as the regulatory CMC representative on project teams to identify and assess regulatory CMC risks and implementing filing readiness strategies that mitigate risk
Author and/or review CMC submission components for post-approval changes
Coordinate CMC submission activities with global colleagues for timely submissions and approvals
Support department and business initiatives while ensuring compliance with global regulatory CMC requirements
Manage diverse relationships and resolve complex regulatory CMC issues while taking into account global regulatory requirements
Advanced degree in a scientific discipline
5-7 years of industry experience in pharmaceutical or biotech company
5+ years of experience working in regulatory affairs CMC including managing post-approval changes for commercial products
Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Experience in leading and writing CMC submissions is required
Strategic thinking and strong problem solving skills
Strong interpersonal skills and the ability to communicate effectively with cross-functional teams
Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations
Experience with post approval management of Quality by Design (QbD) filings, as well as experience with global filings highly desirable

Senior Manager Regulatory Cable Resume Examples & Samples

Reporting to the Director, Regulatory-Content Distribution and Broadband Policy, and supporting VP, Regulatory-Media, the primary accountability is to manage cable-related regulatory matters, as well as specific media-related projects
Draft and oversee progress of CRTC applications/interventions
Assist and participate in the preparation and conduct of regulatory hearings/appearances related to cable and, where required, media
Summarize relevant CRTC decisions/policies and identify operational ramifications and solutions for senior management, functional contacts and employees, where appropriate
Track CRTC decisions/notices/releases and maintain key dates/process descriptions
Liaise with external parties (including other industry members) regarding the preparation of submissions and participate in industry committees as a representative of Rogers
Participate on cross-functional work teams as appropriate
General activities and related projects, as required
Strong problem-solving skills and detail orientation

Manager / Senior Manager Regulatory Afffairs Resume Examples & Samples

Manage planning, preparation, and submission of clinical trial applications (CTAs) and marketing applications (MAs) in the US and internationally
Manage CTA and MA maintenance activities
Provide strategic regulatory insight to cross-functional project teams regarding product development
Serve as primary point of contact with regulatory health authorities
Manage and/or mentor multiple associate-level direct reports
Exercise discretion and independent judgment in the performance of the duties described above
Minimum of 6 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis
Minimum of 3 years of experience in managing regulatory staff
Skilled at gathering regulatory information and developing product approval strategies
Proven track record of managing critical projects as a part of an interdisciplinary team
Proven track record of successfully interacting with regulatory health authorities
Prior experience managing regulatory submissions to deadlines
Thorough understanding of relevant drug development regulations and guidelines
Outstanding interpersonal and communication (written and verbal) skills
Effective task planning and coordination abilities

Senior Manager, Regulatory Resume Examples & Samples

Assist and participate in the preparation and conduct of regulatory hearings/appearances related to Cable and, where required, Media
Identify and conduct research related to CRTC policies and company/industry filings
Advise specific functional groups about regulatory obligations and ensure compliance
Track and respond to complaints from the CRTC and develop compliance mechanisms where required
Law or post-secondary degree (e.g. MBA, Masters in Communications) combined with 5-7 years of demonstrated work experience in broadcasting and/or telecommunications field
Strong interpersonal, communication and presentation skills
Excellent written work, coupled with proven research skills
Solid time-management skills with the ability to effectively handle multiple projects simultaneously and operate independently in a changing fast-paced environment
Computer literacy, including familiarity with Word, Excel and Power Point
Bilingualism and knowledge of finance is an asset

Senior Manager Regulatory Controls Anti-money Laundering Compliance Resume Examples & Samples

Certified Anti-Money Laundering Specialist (CAMS) certification
Master's degree in Business Administration
Employment Type:Full Time

Senior Manager, Regulatory Promotions Resume Examples & Samples

Ensure that projects are completed on schedule following established procedures and timelines
Develops solutions to complex problems, which require a high degree of ingenuity, creativity, and innovation
Schedule and facilitate meetings serving as the single point of contact for meeting coordination
Ensure consistency across functions for coordination of submissions, categorizing review types and prioritizing materials for review
Document required changes and comments during materials review meetings and communicate final approvals
Ensure active materials are reviewed annually
Participate in implementation of relevant software systems related to Materials Review and perform User Acceptance Testing
Train materials sponsors, reviewers and outside vendors on the process and system
Supports strategic planning, development, workflow modifications, and updating operations guidelines and SOP's
Monitor daily operations and adherence to SOP's
Track and report performance metrics

Senior Manager, Regulatory Strategy Resume Examples & Samples

EMEA Senior Leadership Point of Contact: Act as primary interface to EMEA senior leadership team across all Regulatory Management initiatives
SBS Reg Mgmt Strategy: Act as primary point of contact to GNICS Operational Excellence team for the oversight and review of SBS projects globally. Help define long term strategy and vision of Regulatory Mgmt for SBS
Partner with the Regulatory Management Director to collaborate on the long term vision and strategy of Regulatory Management for the GCP Operational Excellence team
Assess how the business can implement Regulatory change into Amex processes, products, and systems in partnership with GCO, Compliance, Servicing, Risk Management, and Technologies
Design broadscale or project-specific cost-effective solutions that satisfy regulatory/compliance requirements with the right customer experience
Implement and lead select regulatory change in partnership with Technologies, Servicing, and Marketing
Provide leadership updates on project progress and risks
Strong knowledge of the GCP marketing and sales organization
Strong ability to understand process and/or operations management
Innovative thinking in designing and developing solutions against complex issues
Strong collaboration skills and demonstrated ability to network globally
Strong communication skills combined with an ability to interact effectively with senior leaders and business partners
Proven ability to adjust quickly to shifting priorities, multiple demands, ambiguity, and rapid change
Proven experience building and leveraging relationships to drive towards shared outcomes for our customers (i.e. Card Members, clients, partners)
Outstanding project management and organizational skills
Strong knowledge of the GCP products and processes preferred
This position will be located in the UK

Senior Manager, Regulatory Initiatives Resume Examples & Samples

8+ years previous experience in project management and/or regulatory reform initiatives or significant work experience in a GWM environment
Excellent problem solving, negotiating skills and highly developed influencing skills
Must maintain a current awareness of regulatory requirements and industry best practices in operational risk
Strong relationship building competencies to build/maintain productive relationships with key stakeholders and business unit partners
Proven track record of meeting deliverables
Expert knowledge of Excel, PowerPoint, Word, and Visio

Manager / Senior Manager, Regulatory Systems Resume Examples & Samples

Plan, implement and maintain software and systems in support of Regulatory Affairs
Activities include Regulatory application administration, project management, business analysis, end user training, issue identification/troubleshooting, new system installation, report development, ancillary software support, maintenance of system security and performance
Serve as the primary interface with Regulatory system users and vendor contacts
Manage Regulatory system validation projects and other compliance efforts
Should be familiar with the operation and use of off-the-shelf Regulatory systems relative to document management, electronic publishing, dossier viewing, information management, Regulatory intelligence and analytics, product registration
Serve as liaison with outside vendors during installation, modification, training, and development of Regulatory application software
Serve as liaison with IT, CIS, and QAV groups
Develop and maintain applicable SOPs, work practices and training guides; ensure documents reflect current practices and are consistent across documents
Develop system-specific procedures, programs, scripts, or web pages, as required
Create user documentation and train personnel on applications/reports/solutions, as required
Monitor software requirements, determine application utilization, and recommend upgrades/enhancements, as needed
Monitor and respond to application problems using appropriate problem determination tools; track problem occurrence and resolution; identify, diagnose and repair complex problems; take corrective action to prevent or minimize system issues
Troubleshoot to resolve Regulatory system-related problems; coordinate with relevant IT/CIS staff and/or third party vendors regarding user support and problem resolution
Provide project leadership in planning, design, implementation and support of business applications; ensure interface with existing application, network and operational server environments
Develop and implement operational standards and procedures for Regulatory applications, including those for performance, backup, and security; interface with IT/CIS staff for development and monitoring of off-hours and special procedures
Manage validation processes for Regulatory systems, including creation of appropriate SOPs and procedures, preparation of submittals, audits of system operation parameters
Bachelor’s degree, preferably in a scientific discipline, Computer Science or related technical/scientific field, or equivalent experience
5-10+ years of experience in Regulatory Affairs, Regulatory Operations or Information Services in the pharmaceutical/biotechnology industry
High level of technical expertise and extensive knowledge of Regulatory applications and support techniques
High level of expertise in project management as related to the selection, installation, and management of application software and systems
Experience with Regulatory applications involving document management, electronic publishing, dossier viewing, information management, regulatory intelligence and analytics, and product registration preferred
Experience with end user training, troubleshooting, and software development assistance
Fast paced office environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required

Senior Manager, Regulatory & Audit Liaison Resume Examples & Samples

Acts as the Global AML/ATF Operations liaison (go-to-person) for audits (internal/external) that relate to all topics (systems, process, procedures) in relation to the unit’s operation as follows
Ability to research viable solutions through existing departments in the Bank or external vendor partners
Excellent written and verbal skills required to prepare communications and interact effectively with other Bank departments, external parties and Senior Executive Officers
Strong knowledge of project planning and tracking techniques and methodologies and market trends
High level understanding of applicable business line objectives
Thorough knowledge of related regulatory requirements including KYC, AML, Anti-Terrorist Financing Policies legislation and procedures
Thorough knowledge of the Bank's interactive systems including Excel, PowerPoint and Word
Working knowledge of Process Mapping and Business Architecting, including use of related software and tools (e.g. Visio )
Previous experience in an Audit/Risk Management role would be an asset
Results oriented, highly motivated with a keen ability to influence others
Self-reliant and pro-active approach to work
Strong analytical, problem-solving and critical thinking skills

Senior Manager Regulatory Development Resume Examples & Samples

Monitors, assesses, and communicates legislative, regulatory, and case law changes for the Global Banking and Markets business area
Minimum of 10 years progressive legal, audit, compliance, financial services operations, and/or regulatory experience, or equivalent with focus on Global Banking and Markets/Securities business
Detailed understanding of the laws, rules, and regulations applicable to Global Banking and Markets and the ability to maintain that knowledge in a rapidly developing environment
Bachelor’s degree in business, finance, accounting, related field or equivalent experience
Strong interpersonal, organizational, communications, analytical, and project management skills
Basic (move thorough to manager) knowledge of products, services, operations and systems and understanding of laws, regulations, and regulatory agencies related to assigned areas

Senior Manager, Regulatory Strategy Resume Examples & Samples

Coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change activities
Provide in-depth reviews of protocols, reports, presentations, and other documents
Manage timelines to ensure approvals are timely and development objectives are met
Participate in the electronic review and quality verification of regulatory submissions
Manage regulatory data and information within systems

Senior Manager Regulatory Supervisory Analytics Resume Examples & Samples

Providing overall management direction for the Portfolio Aid tool
Ensuring consistency of the Portfolio Aid utilization across the Country through regular communications, training and education
Ensure that changing regulations are incorporated into the Portfolio Aid tool and that improvements are incorporated into each release
Detailed knowledge of IIROC and MFDA Tier I and Tier 2 supervisory requirements
Knowledge of securities products
Ability to quickly understand business processes and their risk implications, analyze complex situations, reach appropriate conclusions and make practical recommendations
Comfortable working with a wide variety of internal information systems
Experience in a financial services firm
High level communication skills both written and verbal
Excellent customer service skills and negotiation/conflict resolution skills
Proven relationship skills with an ability to deal effectively with staff at all levels
Experience with managing and influencing people