Regulatory Affairs Analyst Resume Samples

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F Kreiger

Frank

Kreiger

2915 Lucienne Cove

Los Angeles

+1 (555) 351 2336

2915 Lucienne Cove

Los Angeles

Phone

p +1 (555) 351 2336

Experience Experience

Phoenix, AZ

Regulatory Affairs Analyst

Phoenix, AZ

Cronin-Bahringer

Phoenix, AZ

Regulatory Affairs Analyst

Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints
Develops regular reports and presentation materials on regulatory complaint trends for senior management
Works closely with other business units (primarily legal, rates and development) on various projects and dockets
Provides initial regulatory and safety review of products under consideration and prepares preliminary findings to manager
Monitors state and national regulatory proceedings and provide timely summaries to senior management
Perform other duties as assigned by management
Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation

Detroit, MI

Corporate & Investment Bank Office of Regulatory Affairs Analyst

Detroit, MI

Sporer-Marvin

Detroit, MI

Corporate & Investment Bank Office of Regulatory Affairs Analyst

Taking responsibility for regular management reporting
Partnering with other regional secretariats on projects to support the wider regional governance agenda and annual work plan
Producing drafting and research for ORA’s various management reports, both regional and global
Supporting the technical approach to specific regulatory change dossiers; and
Drafting position papers, response documents and other analytical pieces for a variety of audiences, including through industry associations
Leveraging a network of internal stakeholder relationships in order to assist in timely resolution of all matters/requests relating to UKMC actions, processes and reporting
Preparing and reviewing materials, meeting logistics, agenda planning, etc

present

Detroit, MI

Senior Regulatory Affairs Analyst

Detroit, MI

Willms-Hane

present

Detroit, MI

Senior Regulatory Affairs Analyst

present

Assist the Product Safety Team with making product safety determinations and provide input/direction on Medical Device Vigilance activities
Assist in SOP development and review
Perform basic document management tasks including file transfer, storage, tracking, and archival
Assist in the development of regulatory strategy and update strategy based upon regulatory changes
Develop regulatory strategies, templates and documentation for product registrations for each new or modified product
Project management, writing, coordination, and execution of regulatory items
Performs a variety of complicated tasks

Education Education

Bachelor’s Degree in Creativity

Arizona State University

Bachelor’s Degree in Creativity

Skills Skills

General understanding of SEC and FINRA rules/regulations, industry practice and how they apply to Stifel policies and procedures
Excellent analytical, organizational, oral and written communications skills
Strong interpersonal skills
Expertise with Microsoft Office suite
Health insurance and/or health care industry work experience
Familiarity with Visio and Access
Knowledge of Medicaid
Manages regulatory complaint intake processes to ensure accurate case tracking, issue management, and timely compliance with regulatory due dates
Drafts, revises, and reviews the Company's responses to customer inquiries submitted to regulatory agencies concerning important and sensitive regulatory topics to ensure the Company's interests and policies are thoughtfully and accurately articulated
Conducts meetings and coordinates with internal groups on a regular basis to thoroughly investigate customer issues concerning important and sensitive regulatory topics, and ensure outcomes are consistent with the Company's policies and its regulatory commitments

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15 Regulatory Affairs Analyst resume templates

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Regulatory Affairs Analyst Resume Examples & Samples

Bachelor’s Degree; prefer Economics or Finance emphasis
Series 7 and 63/66 required; prefer Series 24, 9 and 10, insurance licenses or ability to obtain
General understanding of SEC and FINRA rules/regulations, industry practice and how they apply to Stifel policies and procedures

Regulatory Affairs Analyst Resume Examples & Samples

Minimum Bachelor of Science or Bachelor of Arts with focus on biology, chemistry, biochemistry or toxicology
Excellent project management and multi-tasking skills
Excellent problem solving, organizational, prioritization and time management skills
Team player, able to build, foster and nurture relationships with members of cross-functional teams and outside of organization
Knowledge of chemistry and broad cosmetic/drug regulatory experience preferred
Fully proficient and experienced with Windows Office, Excel and Outlook and computer applications
English – both written and verbal proficiency, other language(s) desirable

Compliance Regulatory Affairs, Analyst Resume Examples & Samples

Liaising with the FCA to co-ordinate and arrange regulatory audits and reviews
Working with other Compliance areas and the business to produce responses to information requests ahead of such audits/reviews; assist in the preparation for, and attend, related onsite meetings with the FCA
Experience in a financial services-related environment. Previous Compliance experience is not a pre-requisite. Background in equities or derivatives trading (or Legal) of particular interest
Keen to learn new information, adopt new skills and with the ability to identify and make improvements to systems and processes
Calm, with good oral, interpersonal and written communications skills and an authoritative manner
Concern for accuracy, with good attention to detail

Regulatory Affairs Analyst Resume Examples & Samples

Bachelor's degree and related work experience
Excellent analytical, organizational, oral and written communications skills
Expertise with Microsoft Office suite
Health insurance and/or health care industry work experience
Familiarity with Visio and Access
Knowledge of Medicaid

Regulatory Affairs Analyst Resume Examples & Samples

Assist in researching the application of bank regulatory capital rules to current and contemplated business models, potential transactions and events
Develop an understanding of complex compliance and regulatory requirements applicable to the banking industry
Research, track and report emerging regulatory issues with may involve analysis of regulatory issues relative to relevant regulatory capital provisions
Conducting thorough research and analysis on regulatory capital, regulatory accounting and reporting, and certain other regulatory matters, as warranted, presenting results in a clear and concise manner
Assist with coordination of correspondence with regulatory agencies, examination management (as applicable) and responding to regulatory requests

Senior Regulatory Affairs Analyst Resume Examples & Samples

Bachelor’s Degreein Business, Finance or related field
Series 7 and 63/66, 9 and 10 required
Minimum 5 years industry experience required, preferably in Compliance
A strong understanding of SEC, FINRA, MSRB rules/regulations, industry practice and how they apply to Stifel and affiliated firm policies and procedures
Developing, and maintaining constructive and cooperative working relationships with others, and sustaining them over time
Able to gather information from research, existing documentation and subject matter experts, and effectively explain complex ideas to technical and non-technical audiences

Associate Regulatory Affairs Analyst Resume Examples & Samples

At least one year of experience in an office environment
Proven ability to meet deadlines with accuracy
Proven ability to perform routine tasks accurately

Regulatory Affairs Analyst Resume Examples & Samples

Manages regulatory complaint intake processes to ensure accurate case tracking, issue management, and timely compliance with regulatory due dates
Drafts, revises, and reviews the Company's responses to customer inquiries submitted to regulatory agencies concerning important and sensitive regulatory topics to ensure the Company's interests and policies are thoughtfully and accurately articulated
Conducts meetings and coordinates with internal groups on a regular basis to thoroughly investigate customer issues concerning important and sensitive regulatory topics, and ensure outcomes are consistent with the Company's policies and its regulatory commitments
Develops and manages case analytics practices, and implements new methodologies to identify patterns and trends concerning important regulatory topics
Develops regular reports and presentation materials on regulatory complaint trends for senior management
Represents department in meetings with internal business units to advise them of regulatory complaint issues and ensure programmer compliance with customer facing regulatory requirements
Assists attorneys in developing, researching and revising customer-facing messaging on escalated regulatory topics for use by legal-regulatory affairs and other internal groups
Oversees the development and expansion of the Company's regulatory contacts database
Manages special legal regulatory projects, ad hoc research and other related activities as needed

Senior Regulatory Affairs Analyst Resume Examples & Samples

Bachelor’s Degree in Business, Finance, or related field
5 years industry expereince required, preferably in Compliance
Series 7 and 63/66 required; prefer Series 9 and 10
The candidate exercises discretion and independent judgment

Corporate & Investment Bank Office of Regulatory Affairs Analyst Resume Examples & Samples

Contributing to policy priorities through ad hoc projects and research/analysis
Taking responsibility for regular management reporting
Supporting the technical approach to specific regulatory change dossiers; and
Supporting the UKMC and supporting secretariat processes, assisting in the identification and escalation through the governance framework of significant issues to EMEA CIB
Producing drafting and research for ORA’s various management reports, both regional and global
Creating PowerPoint slides to reflect the firm’s policy priorities and objectives
Contributing to analysis of legislative and regulatory proposals on a variety of upcoming financial regulatory change initiatives in terms of application to and impact upon current JPM business. Proposals are predominantly EU and UK driven but are considered, where relevant, in the context of the international agenda e.g. IOSCO, FSB, and emerging US policy, to ensure a holistic appreciation of policy goals
Building relationships and working with a wide range of stakeholders (line of business, compliance, legal, government relations, and finance) in determining the firm's views on proposals and the appropriate mechanism for advocacy/response
Drafting position papers, response documents and other analytical pieces for a variety of audiences, including through industry associations
Execution of specific reporting requirements in relation to the UKMC secretariat function. This will involve taking appropriate minutes, action tracking and follow up to evidence management oversight, challenge, actions and decision making
Partnering with other regional secretariats on projects to support the wider regional governance agenda and annual work plan
Preparing and reviewing materials, meeting logistics, agenda planning, etc
Preparation of reports for the Deputy Regional CEO and liaison with the OTS
Leveraging a network of internal stakeholder relationships in order to assist in timely resolution of all matters/requests relating to UKMC actions, processes and reporting
Ongoing commitment to enhance meeting effectiveness and drive best governance practices
Promotion of open culture to identify/raise risks and challenge existing protocols
Higher degree or professional qualification in a complementary discipline would be a distinct advantage
Demonstrated interest in European Union and/or UK regulatory policy issues, particularly those that affect the financial services industry
Judgment and professional maturity to handle sensitive information and work with senior management
Able to work well both autonomously and in a team environment, holding self accountable for deliverables and able to work to strict deadlines
Excellent verbal/presentation and written communication skills
Ability to manage multiple workflows, including strong time management skills and prioritisation
Microsoft Office skills (Excel, Word and PowerPoint)
Ability to work in an open plan team environment
Competence in a European language would be desirable

Regulatory Affairs Analyst Resume Examples & Samples

Perform data analyses, manipulation and comparisons
Provide product and / or regulatory training to clients and business partners
Triage reimbursement and product issues from clients and business partners
Prepare for Fair Hearings
Behavioral Health experience in New York
1+ years of experience with facility coding, compliance, or reimbursement including outpatient reimbursement methodology
Managed care, and / or compliance expertise
Experience working with the court system structure as it relates to fair hearings

Senior Regulatory Affairs Analyst Resume Examples & Samples

Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work
Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
Project management, writing, coordination, and execution of regulatory items
Completing technical and scientific regulatory assignments that are broad in nature
Usually works with minimum supervision, conferring with superior on unusual matters
Usually handles assignments broad in nature, requiring originality and ingenuity
Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government
Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval,
Assist in the development of regulatory strategy and update strategy based upon regulatory changes
Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review
Advise responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
Coordinate and execute preapproval compliance activities
Determine and communicate submission and approval requirements
Identify issues early in the submission preparation process that could impact product launch
Participate in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance
Monitor applications under regulatory review
Determine trade issues to anticipate regulatory obstacles
Provide regulatory input to product lifecycle planning
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Evaluate regulatory impact on proposed products
Provide input on and review protocol and reports for design verification and validation
Participate in risk-benefit analysis for regulatory compliance
Participate in design reviews of products under development
Responsible for product release approval
Maintaining regulatory paper and electronic files
Review of advertising and promotional items
Review collateral material associated with new launches and ongoing product support
Assist in SOP development and review

Senior Regulatory Affairs Analyst Resume Examples & Samples

Triage federal regulatory questions and issues from clients and business partners
4+ years of experience in a health care regulatory environment
Proficiency in tracking and data reporting
Process improvement orientation
Managed care experience
Compliance expertise

Senior Regulatory Affairs Analyst Resume Examples & Samples

Perform basic document management tasks including file transfer, storage, tracking, and archival
Maintain familiarity with current global regulatory submission standards
Familiarity with departmental standard operating procedures and work instructions
Contribute to department best practices
Provide support to currently marketed products
Responsible for creation and maintenance of submission plans
Responsible for activities which lead to and maintain domestic and international regulatory approval of biopharmaceutical products.　
Responsible for obtaining appropriate Regulatory Intelligence
Responsible for the preparation of submission documents
Responsible for compilation of technical documents (Dossiers) for submission to various overseas regulatory agencies
Synchronize with various departments (Research & Development, QA, QC and Production, etc.) to collect required input for regulatory submissions
Fluent verbal and written English & Spanish
4 to 6 years experience in an industry-related environment or regulatory knowledge experience

Assoc Regulatory Affairs Analyst Resume Examples & Samples

Ensure Regulatory Compliance of our marketed products and regulatory maintenance (i.e. ingredient compliance, labeling, advertising, etc.) in accordance with local regulations, and other applicable legislation, while keeping our products competitive with regard to claims, labeling and advertising
Provide regulatory or technical information and documentation on our products and regulatory initiatives to external, and internal customers (i.e. Marketing, Legal, R&D)
Maintain databases of nutrition and ingredient information relevant to regulatory affairs used for both internal and external functions
Provide Regulatory Support for Launch of New Products. Prepare, and review labeling for consumer studies and new products and/or claims. Develop label copy for marketed products in the form of LIN development including mandatory product label text, claims and nutritional information
Ensure continued regulatory compliance of marketed products (in area of responsibility) with the local regulations, and all other applicable legislation by: Keep abreast of all product changes and other issues relating to the sale and distribution of marketed products and regular communication with colleagues (Marketing, R&D, QA, Legal, etc.), Support in creating labels, summaries, templates, etc.,
Support the launch of new products by reviewing new product briefing documents and portfolio reviews relevant to regulatory issues, developing LINs and working with graphics to ensure compliance of all product labeling with applicable legislation, and/or market authorizations, where applicable
Manage all paper, electronic files, and information management databases of nutrition, ingredient and claims data relevant to regulatory affairs. Maintain and update the nutrition and ingredient data as necessary. Support the regulatory group in, improving and complementing systems, processes, tools to enhance effectiveness and efficiencies of the RA department
Respond to regulatory and technical inquiries and support new product launches with the appropriate documentation
3+ years of experience in Regulatory Affairs of a Consumer Products Company

Senior Regulatory Affairs Analyst Resume Examples & Samples

Monitor internal and external request for information, notices, proposed rules, and other government notices, proactive research for rulemaking and regulatory change
Summarize and distribute these findings to the Regulatory Affairs Leads for the purpose of responding to inquiries, requests and actions to state and federal regulators
Track new laws and regulations in coordination with Optum Regulatory Affairs
Anticipates policy and regulatory issues and reviews legislation both from a content and political perspective
Manage the Regulatory Affairs SharePoint site, Inside Optum, mailbox and weekly Spotlight
Works with less structured, more complex issues
2+ years of experience in a health care regulatory environment
Identifies moderately complex problems and/or conducts moderately complex analyses

Regulatory Affairs Analyst Resume Examples & Samples

2+ years of experience in a health care regulatory environment (managed care, and / or compliance expertise preferred)
1+ years of experience with understanding of personal care services, skilled nursing facilities, claims payment and/or reimbursement, and pharmacy claims related issues
Exposure to Fair Hearings

Regulatory Affairs Analyst Resume Examples & Samples

Draft necessary language per state mandate or new product initiative
Work through disapprovals by the Departments of Insurance and respond to gain approval
Completing test documents on approved forms
Complete product research when required
Provide answers to daily questions that come in pertaining to the product forms
1+ years of experience with dental, vision, stop loss or transplant products
Demonstrate experience in developing and maintain strong business relationships with internal and external customers
Paralegal or advanced degree
2+ years of healthcare operations experience

Regulatory Affairs Analyst Resume Examples & Samples

Track and report on regulatory changes to our Medicare and Medicaid programs
Coordinate the collection of internal attestations for executive review and interface with executives to submit attestations to government agencies
Coordinate the process for approval of offshore vendors utilized by our Medicare business partners
Maintain our contract data within government agency systems
2+ years of experience in a regulatory or compliance environment
Experience working with the Health Plan Management System and the Centers for Medicare & Medicaid Services
Managed care and / or compliance expertise
Baseline knowledge of SharePoint and eGRC systems
Proficient in Word and a baseline knowledge of Excel programs

Senior Regulatory Affairs Analyst Resume Examples & Samples

Manages and is accountable for own workload
Support health plan operations for Medicare Advantage, PDP and Medicare - Medicaid Plan (MMP) plans across the organization by providing guidance and assistance with development of policies and procedures, and education of Medicare risks and best practices
Partner with business in review of Medicare operational policies, both prior to and during the governance process
Educate and partner with business to influence or provide input with regulatory implementations / activities
Subject matter expert on regulatory requirements for Medicare operations - respond to regulatory questions on operational topics and provide regulatory guidance on business initiatives and process improvement projects
Educate business on compliance matters, new regulations and key regulatory topics from CMS and the industry
Assist with implementation on regulatory changes for our Medicare programs, including confirming understanding and completion
5+ years of experience in a regulatory or compliance environment
2+ years of experience working with Federal Government Programs
Excellent communication skills, verbally and in writing
Excellent interpersonal and relationship building skills across business groups internally and outside the organization / regulatory agencies
Ability to analyze and problem solve with a high degree of accuracy and attention to detail
Experience with the Centers for Medicare & Medicaid Services requirements for operational areas (i.e., Appeals & Grievance, Call Center, Claims, Enrollment, etc)
Ability to effectively understand and communicate detailed and complex information verbally with others, including government officials and senior leadership
Highly collaborative individual with ability to influence others and build strong professional relationships
Baseline knowledge of SharePoint
Proficient in Word and Excel programs
May work in a UnitedHealthcare office
Telecommute opportunity is also available for a qualified candidate

Senior Regulatory Affairs Analyst Resume Examples & Samples

Handle assigned product registration activities; including filing determinations, Technical Files, and international product registrations
Compile information from multiple sources for submissions, guiding the project teams in documenting for submissions, writing summaries and other necessary documentation for submissions
Represent Regulatory Affairs on project teams, providing regulatory guidance and review
Assist the Product Safety Team with making product safety determinations and provide input/direction on Medical Device Vigilance activities
Provide guidance in following regulations; assist in developing rationale and documentation for new product development, product changes, testing, design reviews, labeling changes, packaging changes, material changes, etc
Develop regulatory strategies, templates and documentation for product registrations for each new or modified product

Regulatory Affairs Analyst Resume Examples & Samples

Preparation of registration processes such as new product registration applications,
Renewals, variations, deficiency letters, annual reports and pricing registration applications)
In accordance to CSL Behring strategy
Review and approval of all packaging material in accordance with local legislation and
CSL internal SOPs
Maintain organized all physical and electronic internal files (CSL documentation and
Processes submitted to ANYTSA) in accordance with the local and global SOPs
Maintain the list of all submitted processes to ANYISA updated by date of submission,
Subject and status allowing quick traceability of all products
Keep updated with new legislations, requirements and publications by checking Official
Gazette and participate on the monthly Sindusfarma RA meeting_
Review and approval of all promotional material in accordance with the local legislation
And CRBP
Ensuring compliance with all local and global CSL Behring SOPs, CRBP, policies
And quality system requirements as appropriate to the position including
Prompt report of all adverse reactions, product technical complaints or deviations
To QA and Ph V departments for their assessment and actions in accordance to local
SOPs
Completion of required training and maintenance of personal training records in
Addition to HR and QA files
Graduation in Pharmacy
PhD is desirable
Advance English
Good computer skills
Minimum experience 5 years as a RA Analyst in pharmaceutical industry
Experience with biological products processes in mandatory

Quality & Regulatory Affairs Analyst Resume Examples & Samples

Assess, process, and maintain written documents and drawings in electronic and manual controlled documentation systems per governing procedures and in compliance with external regulations/standards
Bachelor's degree in field with 0-2 years experience
Quality Control experience = 5 years
Strong skills in the use of Microsoft Office

Regulatory Affairs Analyst Resume Examples & Samples

Completes forms and requests originating from government agencies
Provides monthly reporting matrix on national activity of distributed generation
Summarizes and reports on changes in complex rates regulations and any expected impacts on the company
Monitors state and national regulatory proceedings and provide timely summaries to senior management
Works closely with other business units (primarily legal, rates and development) on various projects and dockets
Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities
Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints
Prepares and sponsors testimony to governmental or regulatory agencies
Experience:1+ years

Corporate HR Regulatory Affairs Analyst Resume Examples & Samples

1-3 years HR or other relevant experience; an understanding of performance management and compensation processes a plus; Bachelor's degree (or equivalent) required
Ability to work independently and escalate, as appropriate
Proven ability and desire to learn quickly, be flexible
Operate effectively under pressure
Advanced Excel skills (e.g. pivot tables, formulas for large data sets)
Familiarity with HR systems, data and reporting, e.g. Business Objects, PeopleSoft
Strong PowerPoint skills
Experience managing SharePoint sites a plus

Senior Regulatory Affairs Analyst Resume Examples & Samples

Excellent interpersonal skills and supervisory potential
Computer literate with excellent knowledge of Allergan systems for electronic storage and submission
In-depth knowledge of regulations
LI-ES1

Regulatory Affairs Analyst Resume Examples & Samples

Provides input on regulatory-related issues associated with compliance and achieving the business plan
Prioritize and plan on product registration for his/her respective product lines
Preparing, coordinating and submitting regulatory applications to the local health authority
Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with regular updates on product registration
Ensure product registrations are reviewed and renewed as required
Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education
Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs
Supports tender operations by timely supply of accurate regulatory documents
Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies
Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation
Serves as regulatory consultant to marketing team and government regulatory agencies
Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy
Bachelor's Degree in Pharmacy, Phisioterapy or any other related field
Previous experience in Regulatory Affairs area
Boston Scientific is an Equal Opportunity Employer

Associate Regulatory Affairs Analyst Resume Examples & Samples

Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including International Authorities, including Pre-submission documents, 510k submissions, Drug Master Files, CE/IVD Technical Files
Determines the scope of information/documentation necessary for new registration applications and determines post-approval changes to regulatory agencies
Performs review and approval of documents such as SOPs, WINs, and Specifications (raw material and finished product) for regulatory compliance
Services as RA subject matter expert for the site and keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news
Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations
Ensures regulatory project deadline and performance standards are established and met
Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Support post-market surveillance and vigilance activities
Participate in external regulatory inspections and ISO audits
Participate in customer audits/technical meetings where applicable
Maybe required to perform other related duties as required and/or assigned

Regulatory Affairs Analyst, Post Market Resume Examples & Samples

1 year medical device experience in Regulatory Affairs or Quality preferred
Excellent writing skills
Customer service oriented with a positive, self-motivated attitude
Strategically minded with an ability to focus on details

Enterprise Compliance & Regulatory Affairs Analyst Resume Examples & Samples

Minimum of 3 to 5 years professional work experience in health care regulatory analysis or compliance, preferably in a managed care setting
Bachelor’s Degree in Business, Social Science or other relevant field preferred or the equivalent combination of education and experience
Demonstrated competency in regulatory research and analysis
Ability to navigate governmental resources to find information quickly and accurately
Ability to deliver information accurately with insight and perspective
Ability to manage multiple priorities simultaneously and consistently meet deadlines
Ability to review and understand contractual requirements

Regulatory Affairs Analyst Resume Examples & Samples

Monitor business activities to ensure the firm remains in compliance with is policies and procedures as well as industry regulations
Manage registrations on-boarding process for broker dealer to include licensing, complaints and firm required disclosures
Perform assigned supervisory control tests and documents finding
Review and analyze compliance monitoring reports and other related source documents as assigned for suspicious/unusual patterns of activity.Follow up with responsible area(s) for explanations and discussions for appropriate action
Research securities rules and regulations particularly as these impact areas of responsibility
Provide guidance, education and training to business lines, firm employees and representatives on current and changing industry rules, regulations, compliance matters, firm policies and best practices
Review internal and external communications including sales and marketing literature, advertisements and educational materials
Assist in obtaining information for response to regulatory inquiries and investigations as requested
Develop positive relationships with business line partners
Participate in specific compliance related projects as may be assigned from time to time
This list of duties and responsibilities is not intended to be all-inclusive and can be expanded to include other duties or responsibilities that management deems necessary

Regulatory Affairs Analyst, Senior Resume Examples & Samples

This position can be located in either Harrisburg or Philadelphia
Bachelor's degree required; Master's degree preferred
Three to five years’ experience, preferably a Medicaid managed care environment but minimally in a health care, or insurance (managed care) industry or related government environment, at a similar level of autonomy and responsibility as described above

Regulatory Affairs Analyst Resume Examples & Samples

Conducting research and preparing for NYS Fair Hearings, including but not limited to: conducting a timeline review of events, collecting evidence, preparing an evidenciary packet, and drafting a written submission for the Fair Hearing
Narrate a story both verbally and in a clear and concise written format
Personally attend hearings and present the Plan’s position to an Administrative Law Judge (ALJ) at the hearing offices in downtown Brooklyn, attend hearings via telephone for the rest of NYS, and support the team in complying with Fair Hearing decision
Analyzes and investigate
System knowledge with any of the following: Facets, eMedNy, Care1/IQ, ECAA

Regulatory Affairs Analyst Resume Examples & Samples

Arranges for timely submissions of the variation notifications/applications and responses in liaison with subsidiary registration managers when needed
Responsible for all registration process in Panamá (Registration application,renewals, variations and notifications)
Supports the harmonization artworks for CACAR
Does the requirements and follow up at the request of analytical standards and samples for CACAR
Supports the answers of technical concepts generated for CACAR authorities
Plan and perform a regulatory process including preparation of documents for New Registrations, Renewals and PACs for E Salvador, Venezuela and islands
Submission, follow up before the Agency and notification of approval letters
Does follow up at Pharmacovigilance cases reported in the region
Assists with administrative support during filing and review of any centralized submission to safeguard submissions according to CACAR requirements
Provides other administrative support to CACAR Regulatory Liaison as needed
Education: Veterinary or Pharmaceutical Degree
Specialty Science related to animal health of pharmaceutical industry (desirable)
Experience: More than one year in Regulatory Affairs at Pharmaceutical Industry
Good knowledge of GMP and local regulations
English (Reading, writing and speaking) –Medium-advanced level
Knowledge: Central America & Caribbean legal regulations
Leadership behaviors

Regulatory Affairs Analyst Resume Examples & Samples

Support the completion of registration dossiers class I and II (low risk products)
Make the most updated instructions for use and labeling available for relabeling procedure according the documents version
Review the information from Brazil in the instructions for use published at the company website
Support to provide Regulatory documents and information when requested by the customers

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