Regulatory Affairs Analyst Resume Samples

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FK
F Kreiger
Frank
Kreiger
2915 Lucienne Cove
Los Angeles
CA
+1 (555) 351 2336
2915 Lucienne Cove
Los Angeles
CA
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
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

1

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
2

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
3

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
4

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
5

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
6

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
7

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
8

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
9

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
10

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
11

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
12

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
13

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
14

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
15

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
16

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
17

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
18

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
19

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
20

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
21

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
22

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
23

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
24

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
25

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
26

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
27

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
28

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
29

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
30

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
31

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
32

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
33

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
34

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
35

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