Senior Manager, CMC Regulatory Affairs (Biologics)
Travere Therapeutics
August 30, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
The Senior Manager, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs for biologic products. Leads global CMC regulatory strategies supporting clinical development, marketing applications, and lifecycle management, 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, develop mitigation strategies, and provide recommendations.
- Lead preparation, review, and submission of CMC documentation for global filings (INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, annual reports).
- Author/review Module 2 and Module 3 content; coordinate cross-functional submission inputs.
- Support registration milestones and global expansion filings.
- Lead Health Authority interactions related to CMC topics; support inspection readiness and regulatory assessments.
- Develop lifecycle management filing strategies for post-approval CMC changes (process changes, analytical method updates, specs, site transfers, process validation, comparability).
Technical Leadership for Biologics Development:
- Provide regulatory guidance for biologics modalities (mAbs, recombinant/fusion proteins, complex biologics).
- Guide regulatory strategy for cell line development, upstream/downstream processes, scale-up, process validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing and technology transfers; support comparability and analytical characterization/control strategies.
Education/Experience Requirements:
- Bachelor’s degree in a scientific discipline required; advanced degree preferred.
- 7+ years Regulatory Affairs experience with significant CMC regulatory experience.
- Demonstrated biologics experience from early development through commercialization; strong Phase 3/late-stage experience.
- Experience with global submissions (BLAs, MAAs, NDAs, INDs, IMPDs, CTAs).
- Extensive CMC regulatory leadership for biologics (especially mAbs/recombinant proteins).
Additional Skills/Requirements:
- Comprehensive understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC requirements.
- Strong technical knowledge of biologics manufacturing, analytical methods/characterization, CQAs/QTPPs, control strategies, and comparability.
- Preferred: experience with rare disease/orphan indications.
- Ability to travel up to 10%.
- Essential function: face-to-face work with colleagues and/or onsite in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being offerings; wellness/support programs; life insurance, disability; retirement with employer match; generous paid time off.
Compensation:
- Target base pay range: $132,000.00–$172,000.00.
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Senior Manager, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs for biologic products. Leads global CMC regulatory strategies supporting clinical development, marketing applications, and lifecycle management, 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, develop mitigation strategies, and provide recommendations.
- Lead preparation, review, and submission of CMC documentation for global filings (INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, annual reports).
- Author/review Module 2 and Module 3 content; coordinate cross-functional submission inputs.
- Support registration milestones and global expansion filings.
- Lead Health Authority interactions related to CMC topics; support inspection readiness and regulatory assessments.
- Develop lifecycle management filing strategies for post-approval CMC changes (process changes, analytical method updates, specs, site transfers, process validation, comparability).
Technical Leadership for Biologics Development:
- Provide regulatory guidance for biologics modalities (mAbs, recombinant/fusion proteins, complex biologics).
- Guide regulatory strategy for cell line development, upstream/downstream processes, scale-up, process validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing and technology transfers; support comparability and analytical characterization/control strategies.
Education/Experience Requirements:
- Bachelor’s degree in a scientific discipline required; advanced degree preferred.
- 7+ years Regulatory Affairs experience with significant CMC regulatory experience.
- Demonstrated biologics experience from early development through commercialization; strong Phase 3/late-stage experience.
- Experience with global submissions (BLAs, MAAs, NDAs, INDs, IMPDs, CTAs).
- Extensive CMC regulatory leadership for biologics (especially mAbs/recombinant proteins).
Additional Skills/Requirements:
- Comprehensive understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC requirements.
- Strong technical knowledge of biologics manufacturing, analytical methods/characterization, CQAs/QTPPs, control strategies, and comparability.
- Preferred: experience with rare disease/orphan indications.
- Ability to travel up to 10%.
- Essential function: face-to-face work with colleagues and/or onsite in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being offerings; wellness/support programs; life insurance, disability; retirement with employer match; generous paid time off.
Compensation:
- Target base pay range: $132,000.00–$172,000.00.
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.