Regulatory Affairs Analyst Job Description
Regulatory affairs analyst
provides 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.
Regulatory Affairs Analyst Duties & Responsibilities
To write an effective regulatory affairs analyst job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs analyst job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure documents, policies and procedures are reviewed periodically for compliance with regulations and program contracts
Gathers applicable documents and drafts responses to routine and more in-depth regulatory inquiries regarding the firm’s business, policies and/or procedures
In conjunction with the Deputy Director of Regulatory Affairs, acts as compliance liaison during regulatory examinations of the firm and its affiliates including gathering documents, setting up meetings with various departments, and acts as the Compliance representative at the meetings
In conjunction with the Deputy Director of Regulatory Affairs, works with other departments to resolve issues noted in regulatory examinations, drafts responses to regulatory examinations and performs follow-up to ensure deficiencies are corrected
Reviews the annual FINRA Exam Priorities letter and notifies effected business units of the examination focus
Assists the team as needed in the development of new or revised policies and procedures for the firm by attending applicable meetings, giving input, performing research, producing written drafts, making changes and assisting with implementation
Performs compliance-related reviews to various inquiries or projects and determines whether they fall within the firm’s guidelines
Provides back-up for monthly duties performed by the Regulatory Affairs Coordinator
Corresponds and interacts with regulators on relevant issues
Corresponds and interacts with various business units throughout the Firm and its affiliates
Regulatory Affairs Analyst Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs Analyst
List any licenses or certifications required by the position: GMP, CMC, RAC, ISO, CRE, CSQE, CQA, CQE, ASQ, FTA
Education for Regulatory Affairs Analyst
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs analyst job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Business, Engineering, Education, Finance, Life Sciences, Technical, Pharmacy, Chemistry, Sciences
Skills for Regulatory Affairs Analyst
Desired skills for regulatory affairs analyst include:
Banking and lending
Existing and emerging regulations
Guidance documents
Relevant business practices and procedures in professional field
Standards
Microsoft Office Suite
Regulations
Industry practices
Manufacturing and Development
Microsoft Excel
Desired experience for regulatory affairs analyst includes:
Performs clerical duties such as logging information, follow-up phone calls, photocopying, establishing files, and gathering documents as necessary
Performs other duties as assigned by Chief Compliance Director or Deputy Director of Regulatory Affairs
Validates and analyzes data, documents, and information delivered to regulatory entities
Compliance liaison and compliance expert pre, post and during regulatory examinations of the firm and its affiliates including gathering documents, completing questionnaires surrounding the firm’s business, attend meetings with various departments
Strong ability to analyze reports and data regarding trading with emphasis in areas such as OTC fixed income, trading ahead, mark-up reviews, Reg M, OATS, TRACE, SEC Rule 604, investment banking chronologies and market timeliness, to name a few
Works with other departments to resolve issues noted in regulatory examinations, drafts responses to regulatory examinations and performs follow-up to ensure deficiencies are corrected
Regulatory Affairs Analyst Examples
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Regulatory Affairs Analyst Job Description
Job Description Example
Our company is growing rapidly and is hiring for a regulatory affairs analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs analyst
- Works closely with Manager to review available information including information from data rooms and disseminates data/reports/information to the R&D Regulatory & Product Integrity subject experts
- Assures appropriate project time lines are met
- Gathers feedback from R&D Regulatory & Product Integrity subject experts and consolidates information for review and assessment by the Manager
- Uses reasonable independent judgment based on established regulatory, safety and corporate practices
- Collects and inputs information into appropriate reports, charts, spreadsheets
- Assist Regulatory Affairs Manager with coordination of organization-wide compliance activities
- Coordinate preparations for and document submissions relating to the annual Article 44 survey
- Coordinate preparation and submission of compliance plans and plans of correction
- Coordinate implementation of new legislative requirements and agency policy directives
- Assist the Regulatory Affairs Manager in monitoring and informing senior management about regulatory developments
Qualifications for regulatory affairs analyst
- Perform other tasks as assigned by the Regulatory Affairs Manager
- Assessing the regulatory risks and potential impacts
- Completing the control plan of the GS Paris entity
- Maintaining a regulatory and legal watch and implementing it in liaison with the other Compliance departments of the firm
- Establishing and maintaining the appropriate plans and processes to ensure compliance
- Reviewing client files, transaction and marketing materials
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Regulatory Affairs Analyst Job Description
Job Description Example
Our company is hiring for a regulatory affairs analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs analyst
- Responsible for the tracking of regulatory findings and open issues across the bank
- Provides clear and concise communications to regulators and executive and senior management
- Reviews and analyzes business line communications and management action plans relating to regulatory issues
- Participates in meetings with regulators and executive and senior management and keeps records of such meetings
- The IT Lead, Regulatory Affairs Business Analyst will be responsible for working with the Regulatory Affairs Business Process Capability Owners to translate requirements for IT solutions and develop the Business Case to secure project funding
- IT Technical Application Ownership (TAO) for assigned Regulatory Affairs systems throughout their Lifecycle and maintaining data in the CMDB (Configuration Management Data Base) as needed, is an important aspect of the IT Lead, Regulatory Affairs Business Analyst role
- We expect our new IT Lead, Regulatory Affairs Business Analyst to be able to perform all J&J IT Mandatory Application Lifecycle Upgrades and Platform Migrations such as Operating System Upgrades, standard client software, SDDC move to on premise cloud
- You'll develop deeper knowledge of specific Regulatory Affairs capabilities to help better define appropriate IT solutions
- As IT Lead, Regulatory Affairs Business Analyst you apply compliance requirements within scope of responsibility, provides documentation and participates in compliance activities as required
- Co-ordination of the licenses for controlled substances and other documentation as required from the Dept
Qualifications for regulatory affairs analyst
- Execution of specific reporting requirements in relation to the UKMC secretariat function
- Minimum Bachelor’s degree in the field of computer science, life sciences or business administration with technology as a core component
- Minimum 6 years practical work experience as an IT analyst in a life sciences/healthcare organization
- Good knowledge of enterprise architecture and application development methodologies
- Sound professional experience with software development methodologies
- Current knowledge of industry and business process trends related to Regulatory Affairs is a strong asset
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Regulatory Affairs Analyst Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of regulatory affairs analyst. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory affairs analyst
- CE Marking – Regulatory requirements (ref
- Review and perform RA investigation for medical device complaints, and determines the resolution of the complaint with general direction from supervisor and or more experienced staff
- Determine if further inquiries are required with field resources (ESS, TT, Sales Rep or customer)
- Perform follow up inquiry and documents all communications in compliance with MSG good documentation practices and department procedures with general direction from supervisor and or more experienced staff
- Determine if a reported event classifies as a Medical Device Reportable as defined by various regulatory agency
- File proper documentation with applicable agencies as required
- Prepare and submit MDRs Supplemental reports for review to Supervisor in a timely manner
- Ensure work performed is accurate and complete
- Coordinate MDR investigations with Infection Control staff
- Monitor and track progress of any outside laboratory evaluation, when necessary
Qualifications for regulatory affairs analyst
- Ability to work independently on multi-disciplinary teams in conducting data analysis
- A Bachelor’s degree in business, finance, law or related discipline or previous work experience in Regulatory Affairs that is equal to a 4-year degree is required
- A minimum of 3-5 years of previous work experience in banking, lending, audit or compliance-related environment is required
- Formal leadership training is an asset
- Flexibility with schedule given that most activities will take place with Europe resources
- Broad understanding of product line capabilities and limitations of existing systems
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Regulatory Affairs Analyst Job Description
Job Description Example
Our company is looking to fill the role of regulatory affairs analyst. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory affairs analyst
- Maintain traceability, and manually and electronically document the applicable elements of the complaint handling process, such as contact records with the external customers, database update, and complaint closure letters Improves the complaint handling process for better efficiency and greater integrity
- Enter complaint and investigation related information in the database
- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process
- Complete the mandatory Quality training subject to the defined timeline
- Applies a wide degree of creativity and latitude
- Correspond and interact with regulators and various business units throughout the Firm and its affiliates
- Obtain information from payers and insurers needed for proper claims submission
- Researches insurer information- addresses, billing requirements
- Replies to external audit requests for records
- Assists with data driven requests
Qualifications for regulatory affairs analyst
- Bachelor's degree in scientific discipline or equivalent is required
- Minimum of 3 years of complaint handling experience in a closely related field in the medical device and or pharmaceutical industry or equivalent is required
- 2-3 years of experience in a FDA regulated industry
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
- Must be able to communicate with others telephonically
- Ability to understand and explain detailed regulatory compliance programs and/or issues
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Regulatory Affairs Analyst Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of regulatory affairs analyst. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory affairs analyst
- Work with the Regulatory Affairs Business Product Owners to translate business needs for IT solutions and develop/document user stories and/or requirements
- Develop deeper knowledge of specific Regulatory Affairs capabilities to help better define appropriate IT solutions
- Provide continuous support across a variety of HR Regulatory programs, primarily focusing on the Staffing Adequacy Framework, HR Control Forums and a suite of processes focused on key stages of the senior employee lifecycle
- Create materials, typically PowerPoint decks, to illustrate concepts and/or assist in coaching partners to continuously manage/guide the process forward
- Assigned internship-long project that candidates will be expected to scope, develop supporting materials and present to team leadership and relevant business partners
- Plans and implements regulatory activities in support of pharmaceutical product lifecycle management, (e.g., Annual reports, label and CMC changes)
- Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with other functions, including regulatory advertising/promotion, medical affairs, and commercial
- Manages the preparation of clinical trial applications and routine clinical trial maintenance submissions
- With supervision, ensures effective preparation of core files for regulatory agency New Drug Applications and line extensions
- With supervision, supports US specific submissions (strategy and package preparation) Orphan Drug and Pediatric Plans
Qualifications for regulatory affairs analyst
- Will be qualified to a minimum of B.Sc
- Fluency in the English language, both orally and in writing
- Finance/ Legal Graduate
- Prior work experience in the financial services industry with focus on regulatory matters
- Must be able to work to tight deadlines, independently and yet still be team-oriented
- University Degree (BSc) or equivalent in life sciences, technical engineering (equivalent to Fachhochschule), work experience in Quality Assurance or Regulatory Affairs would be an asset