Senior Manager, CMC Regulatory Affairs (Biologics)
Travere Therapeutics
August 09, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position Summary:
Senior Manager, CMC Regulatory Affairs—leads global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for biologic development and commercial programs (late-stage/Phase 3; rare disease).
Responsibilities:
- Develop/implement global CMC regulatory strategies for clinical, registration, commercialization, and lifecycle management.
- Lead CMC regulatory activities on cross-functional teams; align CMC plans to global requirements and business objectives.
- Assess regulatory risks; develop mitigation strategies and recommendations.
- Prepare/review/submit CMC documentation for global filings (IND/IMPD/CTA/BLA/NDA/MAA, amendments/supplements/variations, annual reports).
- Author/review Module 2 & 3; coordinate submission contributions and compliance.
- Lead Health Authority interactions and support agency meetings.
- Support inspection readiness and manufacturing/product quality regulatory assessments.
- Drive lifecycle CMC filings and post-approval changes (process changes, method updates, specs, site transfers, validation, comparability).
Qualifications/Required Skills:
- BS in a scientific field; advanced degree preferred.
- 7+ years Regulatory Affairs in biotech/pharma with significant CMC Regulatory Affairs.
- Experience across biologics development (DS/DP manufacturing, analytics, process development/comparability/control strategies), including Phase 3/late-stage.
- Global submission experience (BLA/MAA/NDA/IND/IMPD/CTA).
- Strong knowledge of biologics CMC for mAbs/recombinant proteins; Health Authority CMC interactions.
- Understanding of FDA/EMA/MHRA/PMDA/Health Canada/ICH/global CMC requirements.
- Travel up to 10%; onsite presence in San Diego required (not 100% remote).
Preferred:
- Experience with rare disease/orphan indications.
Benefits:
- Premium health, life insurance, disability, retirement with employer match, generous paid time off, wellness/support programs.
- Target base pay range: $132,000–$172,000 (plus incentive/long-term incentive).
Application instructions:
- Apply on an ongoing basis until selected. Accommodation requests: accommodations@travere.com (online application/interview/hiring process only).
Senior Manager, CMC Regulatory Affairs—leads global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for biologic development and commercial programs (late-stage/Phase 3; rare disease).
Responsibilities:
- Develop/implement global CMC regulatory strategies for clinical, registration, commercialization, and lifecycle management.
- Lead CMC regulatory activities on cross-functional teams; align CMC plans to global requirements and business objectives.
- Assess regulatory risks; develop mitigation strategies and recommendations.
- Prepare/review/submit CMC documentation for global filings (IND/IMPD/CTA/BLA/NDA/MAA, amendments/supplements/variations, annual reports).
- Author/review Module 2 & 3; coordinate submission contributions and compliance.
- Lead Health Authority interactions and support agency meetings.
- Support inspection readiness and manufacturing/product quality regulatory assessments.
- Drive lifecycle CMC filings and post-approval changes (process changes, method updates, specs, site transfers, validation, comparability).
Qualifications/Required Skills:
- BS in a scientific field; advanced degree preferred.
- 7+ years Regulatory Affairs in biotech/pharma with significant CMC Regulatory Affairs.
- Experience across biologics development (DS/DP manufacturing, analytics, process development/comparability/control strategies), including Phase 3/late-stage.
- Global submission experience (BLA/MAA/NDA/IND/IMPD/CTA).
- Strong knowledge of biologics CMC for mAbs/recombinant proteins; Health Authority CMC interactions.
- Understanding of FDA/EMA/MHRA/PMDA/Health Canada/ICH/global CMC requirements.
- Travel up to 10%; onsite presence in San Diego required (not 100% remote).
Preferred:
- Experience with rare disease/orphan indications.
Benefits:
- Premium health, life insurance, disability, retirement with employer match, generous paid time off, wellness/support programs.
- Target base pay range: $132,000–$172,000 (plus incentive/long-term incentive).
Application instructions:
- Apply on an ongoing basis until selected. Accommodation requests: accommodations@travere.com (online application/interview/hiring process only).