Senior Manager, CMC Regulatory Affairs (Biologics)
Travere Therapeutics
June 27, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
Senior Manager, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) across development and commercial biologic programs, with focus on late-stage development, 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 regulatory risks and recommend mitigation.
- Lead preparation, review, and submission of CMC documentation for INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments/supplements, variations, and annual reports.
- Author/review Module 2 and Module 3; coordinate submission contributions and ensure compliance with global requirements.
- Support Health Authority interactions and agency meetings; inspection readiness and CMC-related regulatory assessments.
- Develop global filing strategies for post-approval changes (process changes, analytical updates, specifications, site transfers, validation, comparability).
Technical Leadership for Biologics Development:
- Provide regulatory guidance for biologics (mAbs, recombinant/fusion proteins and complex modalities).
- Support regulatory strategy for cell line development, upstream/downstream development, scale-up, process validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes and technology transfers.
- Support comparability strategies; provide oversight for analytical characterization, control strategies, CQAs, process parameters, and product characterization.
Qualifications:
- Bachelor’s degree in a scientific discipline required; MS/PharmD/PhD preferred.
- 7+ years Regulatory Affairs experience with significant CMC experience in biotechnology/pharma.
- Experience across biologics development through commercialization; Phase 3/late-stage experience.
- Experience with global submissions (BLAs, MAAs, NDAs, INDs, IMPDs, CTAs) and leading CMC activities for biologics.
- Experience with Health Authority interactions; post-approval change management, comparability, and validation.
Additional Skills/Requirements:
- Working knowledge of FDA/EMA/MHRA/PMDA/Health Canada, ICH, and global CMC regulatory requirements.
- Understanding of quality systems, lifecycle management, drug substance/drug product manufacturing, analytical methods/characterization, CQAs/QTPPs and control strategies.
- Rare disease/orphan-indication experience preferred.
- Travel up to 10%; onsite in San Diego required (not 100% remote).
Benefits (explicitly stated):
- Premium health and well-being, life insurance, disability, retirement plans with employer match, generous paid time off.
Compensation (explicitly stated):
- Target base pay range: $132,000.00–$172,000.00.
Application Instructions:
- Applications accepted 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) across development and commercial biologic programs, with focus on late-stage development, 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 regulatory risks and recommend mitigation.
- Lead preparation, review, and submission of CMC documentation for INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments/supplements, variations, and annual reports.
- Author/review Module 2 and Module 3; coordinate submission contributions and ensure compliance with global requirements.
- Support Health Authority interactions and agency meetings; inspection readiness and CMC-related regulatory assessments.
- Develop global filing strategies for post-approval changes (process changes, analytical updates, specifications, site transfers, validation, comparability).
Technical Leadership for Biologics Development:
- Provide regulatory guidance for biologics (mAbs, recombinant/fusion proteins and complex modalities).
- Support regulatory strategy for cell line development, upstream/downstream development, scale-up, process validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes and technology transfers.
- Support comparability strategies; provide oversight for analytical characterization, control strategies, CQAs, process parameters, and product characterization.
Qualifications:
- Bachelor’s degree in a scientific discipline required; MS/PharmD/PhD preferred.
- 7+ years Regulatory Affairs experience with significant CMC experience in biotechnology/pharma.
- Experience across biologics development through commercialization; Phase 3/late-stage experience.
- Experience with global submissions (BLAs, MAAs, NDAs, INDs, IMPDs, CTAs) and leading CMC activities for biologics.
- Experience with Health Authority interactions; post-approval change management, comparability, and validation.
Additional Skills/Requirements:
- Working knowledge of FDA/EMA/MHRA/PMDA/Health Canada, ICH, and global CMC regulatory requirements.
- Understanding of quality systems, lifecycle management, drug substance/drug product manufacturing, analytical methods/characterization, CQAs/QTPPs and control strategies.
- Rare disease/orphan-indication experience preferred.
- Travel up to 10%; onsite in San Diego required (not 100% remote).
Benefits (explicitly stated):
- Premium health and well-being, life insurance, disability, retirement plans with employer match, generous paid time off.
Compensation (explicitly stated):
- Target base pay range: $132,000.00–$172,000.00.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.