Conseiller(ère) en conformité réglementaire chez Promutuel Assurance, assureur québécois. Veille aux obligations légales, à la protection des renseignements personnels et à la gouvernance.
About the role
- Senior Regulatory Affairs Associate tracking global regulations and leading impact assessments. Supporting Parexel’s clinical research and life sciences consulting solutions through regulatory intelligence.
Responsibilities
- Monitor the regulatory intelligence platform and other information sources to identify and track new and evolving regulations, guidelines, standards, and policies from global regulatory bodies
- Review regulatory content for relevance, distribute approved content to key stakeholders for impact assessment and gap analysis, and update stakeholder distribution lists
- Collaborate with subject matter experts to assess implications of regulatory changes on products, development pipelines, and business operations
- Track implementation of impact assessments and gap analyses with key stakeholders
- Analyze and report impact assessment compliance metrics and follow up on risk-mitigation actions
- Use the AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize GxP-related content and update AI taxonomy terms
- Participate in audits and inspections by supplying regulatory intelligence tracking and impact assessment evidence
- Maintain familiarity with global standard operating procedures and working procedures in the document management system
- Coordinate with Information Technology, Regulatory Technology, and the platform vendor on technical problems, access requests, and distribution issues
- Stay current with regulatory intelligence trends and technologies and share learnings to improve compliance activities
Requirements
- Minimum of 2 years of work experience in regulatory intelligence
- Bachelor's degree in a scientific or technical discipline
- Previous experience analyzing and reporting compliance metrics
- Solid working knowledge of drug, biologic, and device development processes, and of the laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH
- Ability to plan, direct, organize, and coordinate projects
- Excellent interpersonal skills, with strong written and verbal communication
- Critical thinking and problem-solving skills
- Results-driven, team-oriented collaborative approach
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook)
- Experience working in clinical research, healthcare, or a regulated environment
- Comfort working with an AI-enabled regulatory intelligence platform, document management systems, and Microsoft Office
- Preferred: Minimum of 2 years of regulatory affairs experience
- Preferred: Previous interactions with the FDA or other health authorities
- Preferred: Previous experience with pharmacovigilance or regulatory work in pharmacovigilance
- Preferred: Previous experience developing newsletters
Benefits
- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- Some roles may also be eligible for additional incentives, bonuses, or other compensation programs
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