Senior Manager, CMC Regulatory Affairs - Small Molecules
Travere Therapeutics
August 18, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position Summary: Senior Manager, CMC Regulatory Affairs. Provide strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs for small molecule drug products, primarily oral solid dosage forms (tablets/capsules).
Responsibilities:
- Develop and execute CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Lead cross-functional CMC regulatory guidance; partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management.
- Assess regulatory risks; develop mitigation strategies and recommendations.
- Support IND through NDA approval and post-approval lifecycle management (including expedited pathways where applicable).
- Lead preparation/review/submission of CMC regulatory documents (INDs, CTAs, IMPDs, NDAs, MAAs, amendments/supplements, variations, annual reports, Health Authority question responses).
- Author/review Module 2 and Module 3 CMC documentation.
- Support initial marketing applications/registration strategies; Health Authority interactions; inspection readiness.
- Plan and support post-approval CMC changes (process/formulation/specification/analytical method/site transfers/technology transfers/validation/stability/supplier changes).
Qualifications:
- Bachelor’s degree in a related scientific field required; MS/PhD/PharmD preferred.
- 7+ years Regulatory Affairs in pharma/biotech with significant CMC Regulatory Affairs experience.
- Strong experience with small molecule products IND-to-commercialization and post-approval lifecycle management; extensive oral solid dosage form experience.
- Demonstrated CMC submission experience; global/regional agency experience (FDA, EMA, GCC, PMDA).
Additional skills: leadership, independent ownership, ability to travel ~10%, and not 100% remote (onsite/face-to-face in San Diego required).
Benefits: premium health, financial/work-life/well-being offerings, wellness programs, life insurance, disability, retirement match, and generous paid time off.
Application instructions: Travere accepts applications on an ongoing basis until a candidate is selected.
Responsibilities:
- Develop and execute CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Lead cross-functional CMC regulatory guidance; partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management.
- Assess regulatory risks; develop mitigation strategies and recommendations.
- Support IND through NDA approval and post-approval lifecycle management (including expedited pathways where applicable).
- Lead preparation/review/submission of CMC regulatory documents (INDs, CTAs, IMPDs, NDAs, MAAs, amendments/supplements, variations, annual reports, Health Authority question responses).
- Author/review Module 2 and Module 3 CMC documentation.
- Support initial marketing applications/registration strategies; Health Authority interactions; inspection readiness.
- Plan and support post-approval CMC changes (process/formulation/specification/analytical method/site transfers/technology transfers/validation/stability/supplier changes).
Qualifications:
- Bachelor’s degree in a related scientific field required; MS/PhD/PharmD preferred.
- 7+ years Regulatory Affairs in pharma/biotech with significant CMC Regulatory Affairs experience.
- Strong experience with small molecule products IND-to-commercialization and post-approval lifecycle management; extensive oral solid dosage form experience.
- Demonstrated CMC submission experience; global/regional agency experience (FDA, EMA, GCC, PMDA).
Additional skills: leadership, independent ownership, ability to travel ~10%, and not 100% remote (onsite/face-to-face in San Diego required).
Benefits: premium health, financial/work-life/well-being offerings, wellness programs, life insurance, disability, retirement match, and generous paid time off.
Application instructions: Travere accepts applications on an ongoing basis until a candidate is selected.