Associate Director, CMC Regulatory Affairs - Biologics
Travere Therapeutics
August 18, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position: Associate Director, CMC Regulatory Affairs
Responsibilities:
- Develop and execute global CMC regulatory strategies supporting clinical development, registration, commercialization, and lifecycle management of biologic products.
- Serve as CMC Regulatory lead on cross-functional program teams; align CMC activities with regulatory objectives and timelines.
- Assess regulatory risks, create mitigation plans, and provide strategic guidance for global (including expedited/rare disease) programs.
- Lead preparation, review, and submission of CMC content for filings (INDs, IMPDs/CTAs, BLAs/NDAs, MAAs, amendments, supplements, variations, annual reports).
- Author/review Module 2 and Module 3 content to ensure compliance with global requirements.
- Lead CMC Health Authority interactions for registration milestones, inspection readiness, and global expansion.
- Develop post-approval CMC change strategies (manufacturing/analytical changes, site transfers, validation, comparability).
- Provide technical regulatory oversight for biologics (CQAs, specs, process parameters, characterization).
Qualifications/Required:
- Bachelor’s in a scientific discipline (or equivalent experience).
- 8+ years Regulatory Affairs experience in biotech/pharma, including significant CMC Regulatory Affairs.
- Strong technical expertise across biologics from development through commercialization (post-approval changes, comparability, lifecycle).
Preferred:
- Advanced degree (MS, PhD, PharmD or equivalent).
Additional required skills:
- Experience developing global CMC regulatory strategies; global submissions experience.
- Deep knowledge of FDA/EMA/MHRA/PMDA/Health Canada, ICH, and CMC regulatory interactions.
- Strong communication, project management, regulatory judgment; matrix leadership; travel ~10%.
Benefits/Compensation (as stated):
- Comprehensive benefits (health, life/disability, retirement match, paid time off, wellness support) and competitive base pay $150,000–$195,000.
Application instructions:
- Applications accepted on an ongoing basis until selected.
Responsibilities:
- Develop and execute global CMC regulatory strategies supporting clinical development, registration, commercialization, and lifecycle management of biologic products.
- Serve as CMC Regulatory lead on cross-functional program teams; align CMC activities with regulatory objectives and timelines.
- Assess regulatory risks, create mitigation plans, and provide strategic guidance for global (including expedited/rare disease) programs.
- Lead preparation, review, and submission of CMC content for filings (INDs, IMPDs/CTAs, BLAs/NDAs, MAAs, amendments, supplements, variations, annual reports).
- Author/review Module 2 and Module 3 content to ensure compliance with global requirements.
- Lead CMC Health Authority interactions for registration milestones, inspection readiness, and global expansion.
- Develop post-approval CMC change strategies (manufacturing/analytical changes, site transfers, validation, comparability).
- Provide technical regulatory oversight for biologics (CQAs, specs, process parameters, characterization).
Qualifications/Required:
- Bachelor’s in a scientific discipline (or equivalent experience).
- 8+ years Regulatory Affairs experience in biotech/pharma, including significant CMC Regulatory Affairs.
- Strong technical expertise across biologics from development through commercialization (post-approval changes, comparability, lifecycle).
Preferred:
- Advanced degree (MS, PhD, PharmD or equivalent).
Additional required skills:
- Experience developing global CMC regulatory strategies; global submissions experience.
- Deep knowledge of FDA/EMA/MHRA/PMDA/Health Canada, ICH, and CMC regulatory interactions.
- Strong communication, project management, regulatory judgment; matrix leadership; travel ~10%.
Benefits/Compensation (as stated):
- Comprehensive benefits (health, life/disability, retirement match, paid time off, wellness support) and competitive base pay $150,000–$195,000.
Application instructions:
- Applications accepted on an ongoing basis until selected.