Associate Director, CMC Regulatory Affairs - Biologics
Travere Therapeutics
August 18, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
- Provide strategic and operational regulatory leadership for CMC (Chemistry, Manufacturing, and Controls) activities across development and commercial programs for biologic products.
- Lead global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management (focused on late-stage/Phase 3 and rare disease therapeutics).
- Serve as primary CMC Regulatory Affairs representative on cross-functional teams; partner with Technical Operations, Process/Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to align CMC plans with global regulatory requirements.
Responsibilities:
- Develop and execute global CMC regulatory strategies.
- Lead CMC regulatory workstreams; assess risks and define mitigation strategies.
- Prepare/review/submit CMC content for INDs, IMPDs/CTAs, BLAs/NDAs, MAAs, amendments, supplements, variations, and annual reports.
- Author/review Module 2 and Module 3 content.
- Lead Health Authority interactions; support registration milestones and inspection readiness.
- Develop post-approval CMC change and lifecycle management regulatory strategies (manufacturing/analytical changes, site transfers, validation, comparability).
- Provide technical regulatory guidance for biologics (mAbs, recombinant/fusion proteins, complex modalities).
- Advise on cell line/process development, scale-up/validation, commercial manufacturing, formulation/fill-finish, and tech transfers; oversee analytical characterization/control strategies (CQAs, CPPs, specs, product characterization).
Qualifications (Required/Preferred) & Skills:
- BS in a scientific discipline (required); MS/PhD/PharmD preferred.
- 8+ years Regulatory Affairs in biotech/pharma with significant CMC Regulatory experience (required).
- Strong technical expertise across biologics development to commercialization (required).
- Demonstrated ability to develop/execute global CMC regulatory strategies; experience with global submissions (IND/IMPD/CTA/BLA/NDA/MAA).
- Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Strong project management, communication, regulatory judgment, and ability to interpret complex technical/scientific information.
- Ability to work independently in a matrixed environment; travel ~10%.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement with employer match; generous paid time off.
- Target base pay range: $150,000–$195,000.
Application instructions:
- Applications accepted on an ongoing basis until a candidate is selected.
- Provide strategic and operational regulatory leadership for CMC (Chemistry, Manufacturing, and Controls) activities across development and commercial programs for biologic products.
- Lead global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management (focused on late-stage/Phase 3 and rare disease therapeutics).
- Serve as primary CMC Regulatory Affairs representative on cross-functional teams; partner with Technical Operations, Process/Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to align CMC plans with global regulatory requirements.
Responsibilities:
- Develop and execute global CMC regulatory strategies.
- Lead CMC regulatory workstreams; assess risks and define mitigation strategies.
- Prepare/review/submit CMC content for INDs, IMPDs/CTAs, BLAs/NDAs, MAAs, amendments, supplements, variations, and annual reports.
- Author/review Module 2 and Module 3 content.
- Lead Health Authority interactions; support registration milestones and inspection readiness.
- Develop post-approval CMC change and lifecycle management regulatory strategies (manufacturing/analytical changes, site transfers, validation, comparability).
- Provide technical regulatory guidance for biologics (mAbs, recombinant/fusion proteins, complex modalities).
- Advise on cell line/process development, scale-up/validation, commercial manufacturing, formulation/fill-finish, and tech transfers; oversee analytical characterization/control strategies (CQAs, CPPs, specs, product characterization).
Qualifications (Required/Preferred) & Skills:
- BS in a scientific discipline (required); MS/PhD/PharmD preferred.
- 8+ years Regulatory Affairs in biotech/pharma with significant CMC Regulatory experience (required).
- Strong technical expertise across biologics development to commercialization (required).
- Demonstrated ability to develop/execute global CMC regulatory strategies; experience with global submissions (IND/IMPD/CTA/BLA/NDA/MAA).
- Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Strong project management, communication, regulatory judgment, and ability to interpret complex technical/scientific information.
- Ability to work independently in a matrixed environment; travel ~10%.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement with employer match; generous paid time off.
- Target base pay range: $150,000–$195,000.
Application instructions:
- Applications accepted on an ongoing basis until a candidate is selected.