Senior Manager, CMC Regulatory Affairs (Biologics)
Travere Therapeutics
August 30, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position Summary:
Senior Manager, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial biologic programs, leading global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management (focus: late-stage/Phase 3 and rare disease therapeutics).
Responsibilities:
- Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Serve as CMC Regulatory lead on cross-functional teams; assess risks and provide regulatory recommendations.
- Lead preparation/review/submission of CMC documentation (INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, annual reports) including Module 2/3.
- Coordinate cross-functional inputs; ensure global regulatory compliance.
- Support registration milestones (first marketing applications, global expansion).
- Lead CMC Health Authority interactions and support agency meetings.
- Support inspection readiness and regulatory assessments; manage post-approval CMC changes (process changes, analytical updates, specs, site transfers, validation, comparability).
Technical Leadership:
- Provide regulatory guidance for biologics modalities (mAbs, recombinant/fusion proteins, complex biologics).
- Support strategies for cell line development, upstream/downstream process development, scale-up, validation, commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes; oversee comparability, analytical characterization, control strategies, and CQAs.
Education/Experience Requirements:
- BS in a scientific discipline required; MS/PharmD/PhD preferred.
- 7+ years Regulatory Affairs in biotech/pharma, including significant CMC Regulatory Affairs.
- Experience from early development through commercialization; strong Phase 3/late-stage and global submissions (BLA/MAA/NDA/IND/IMPD/CTA).
- Extensive experience leading CMC regulatory activities for biologics; manufacturing process development and post-approval change management.
Additional Skills/Requirements:
- Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH global CMC requirements.
- Preferred: experience with rare disease/orphan indications.
- Travel up to 10%; essential onsite capability in San Diego (not 100% remote).
Benefits:
- Premium health, wellness/support programs, life/disability, retirement match, and generous paid time off; target base pay range $132,000–$172,000.
Application Instructions:
- Submit applications; Travere accepts applications on an ongoing basis until a candidate is selected.
Senior Manager, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial biologic programs, leading global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management (focus: late-stage/Phase 3 and rare disease therapeutics).
Responsibilities:
- Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Serve as CMC Regulatory lead on cross-functional teams; assess risks and provide regulatory recommendations.
- Lead preparation/review/submission of CMC documentation (INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, annual reports) including Module 2/3.
- Coordinate cross-functional inputs; ensure global regulatory compliance.
- Support registration milestones (first marketing applications, global expansion).
- Lead CMC Health Authority interactions and support agency meetings.
- Support inspection readiness and regulatory assessments; manage post-approval CMC changes (process changes, analytical updates, specs, site transfers, validation, comparability).
Technical Leadership:
- Provide regulatory guidance for biologics modalities (mAbs, recombinant/fusion proteins, complex biologics).
- Support strategies for cell line development, upstream/downstream process development, scale-up, validation, commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes; oversee comparability, analytical characterization, control strategies, and CQAs.
Education/Experience Requirements:
- BS in a scientific discipline required; MS/PharmD/PhD preferred.
- 7+ years Regulatory Affairs in biotech/pharma, including significant CMC Regulatory Affairs.
- Experience from early development through commercialization; strong Phase 3/late-stage and global submissions (BLA/MAA/NDA/IND/IMPD/CTA).
- Extensive experience leading CMC regulatory activities for biologics; manufacturing process development and post-approval change management.
Additional Skills/Requirements:
- Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH global CMC requirements.
- Preferred: experience with rare disease/orphan indications.
- Travel up to 10%; essential onsite capability in San Diego (not 100% remote).
Benefits:
- Premium health, wellness/support programs, life/disability, retirement match, and generous paid time off; target base pay range $132,000–$172,000.
Application Instructions:
- Submit applications; Travere accepts applications on an ongoing basis until a candidate is selected.