Senior Manager, CMC Regulatory Affairs (Biologics)

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. Leads global CMC regulatory strategies for biologic products supporting clinical development, marketing applications, and lifecycle management, with a focus on late-stage development, Phase 3 programs, and rare disease therapeutics.

Responsibilities:
- Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Lead CMC regulatory on cross-functional program teams; provide strategic regulatory guidance.
- Assess regulatory risks, develop mitigation strategies, and provide recommendations.
- Support expedited programs, orphan drug products, and rare disease indications.
- Lead CMC documentation preparation/review/submission (INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, annual reports).
- Author/review Module 2 and Module 3; ensure consistency across submissions.
- Coordinate cross-functional contributions to CMC filings to meet global regulatory requirements.
- Support registration milestones and global expansion filings.
- Lead CMC-related Health Authority interactions and support agency meetings.
- Support inspection readiness and manufacturing/product quality regulatory assessments.
- Drive lifecycle management and post-approval CMC change strategies (process changes, method updates, specifications, site transfers, validation, comparability).

Technical Leadership for Biologics Development:
- Provide regulatory guidance for biologics modalities (e.g., mAbs, recombinant/fusion proteins).
- Support regulatory strategies for cell line development, upstream/downstream process development, scale-up, validation, and commercial manufacturing.
- Evaluate regulatory impact of manufacturing changes (microbial/mammalian culture, purification, formulation, fill-finish, tech transfers).
- Support comparability strategy development/assessment.
- Provide oversight for analytical characterization programs and control strategies.

Qualifications:
- Bachelor’s degree in a scientific discipline required; advanced degree preferred.
- 7+ years Regulatory Affairs experience with significant CMC experience; biologics development through commercialization.
- Strong experience with Phase 3/late-stage programs and global submissions (BLAs, MAAs, NDAs, INDs, IMPDs, CTAs).
- Extensive experience leading CMC regulatory activities for biologics (mAbs, recombinant proteins).
- Experience with manufacturing process development and commercialization of drug substance and drug product.
- Experience leading Health Authority interactions and post-approval change management/comparability/validation/lifecycle activities.

Required/Preferred Skills:
- Comprehensive understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC requirements.
- Strong biologics CMC knowledge (quality systems, validation, lifecycle management, CQAs/QTPPs/control strategies).
- Technical understanding of drug substance manufacturing and downstream processing; biologic analytical methods/characterization.
- Experience with rare disease/orphan indications preferred.
- Ability to travel up to 10%; onsite in San Diego required (not 100% remote).

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

Compensation (as stated):
- Target base pay range: $132,000.00–$172,000.00.

Application Instructions:
- Apply on an ongoing basis until a candidate is selected.