Senior Manager, CMC Regulatory Affairs (Biologics)

Position Summary:
Senior Manager, CMC Regulatory Affairs—strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) across development and commercial biologic programs, including late-stage/Phase 3 and rare disease therapeutics.

Responsibilities:
- Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Lead cross-functional teams with strategic CMC regulatory guidance; assess risks, mitigate, and recommend actions.
- Prepare/review/submit CMC documentation for global filings (IND, IMPD, CTA, BLA, NDA, MAA, amendments/supplements/variations/annual reports).
- Author/review Module 2 and Module 3; coordinate submission components for global compliance.
- Lead Health Authority interactions; support agency meetings and inspection readiness.
- Develop lifecycle management filing strategies for post-approval CMC changes (process changes, analytical updates, spec revisions, site transfers, validation, comparability).
- Provide regulatory guidance for biologics development (mAbs, recombinant/fusion proteins, complex modalities), including cell line, upstream/downstream, scale-up, validation, tech transfer.
- Support comparability, analytical characterization, CQAs/process parameters/control strategies.

Qualifications:
- BS in a scientific discipline (or equivalent). MS/PharmD/PhD preferred.
- 7+ years Regulatory Affairs in biotech/pharma with significant CMC Regulatory Affairs experience.
- Demonstrated biologics development experience (early-to-commercial), including Phase 3/late-stage.
- Experience with global submissions (BLA/MAA/NDA/IND/IMPD/CTA) and leading CMC activities for biologics.
- Experience with manufacturing process development/commercialization and post-approval change management, comparability, and validation.

Skills/Requirements:
- Strong knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Travel up to 10%; onsite in San Diego with limited remote.
- Preferred: rare disease/orphan indications.

Benefits:
- Premium health, financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.

Application instructions:
- Apply on an ongoing basis until selected; contact accommodations@travere.com for application/interview accommodations only.