Senior Regulatory Affairs Associate, FDA expertise
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements.
- Review, prepare, and submit dossiers; negotiate with HAs to secure approvals.
- Lead regulatory strategies for product launches and integrations at the affiliate level.
- Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes.
- Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure.
Requirements
- 3–5+ years of local regulatory knowledge and experience in a health authority-facing role.
- Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent.
- Advanced degree (Master’s or PhD) preferred in law, legal affairs, or natural sciences.
- Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.
- Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes.
- Proven expertise in managing regulatory submissions, timelines, and cross-functional teams.
Benefits
- Health insurance
- 401(k)
- Flexible work arrangements
- Professional development opportunities
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsdossier preparationregulatory strategiesCAPA closureaudit readinessnegotiationtimelines managementcross-functional team managementregulatory knowledgehealth authority engagement
Soft skills
organizationcoordinationpartnershipcommunicationleadershipproblem-solvingcollaborationstrategic thinkingadaptabilityattention to detail
Certifications
Regional Regulatory Affairs Certification (RAC)Certified Association of Regulatory Professionals (CARP)Certified in Healthcare Compliance (CHPC)