Senior Manager, CMC Regulatory Affairs - Small Molecules

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, focusing on small molecule drug products—primarily oral solid dosage forms (tablets and capsules).

Responsibilities:
- Develop and implement CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
- Lead CMC regulatory workstreams on cross-functional teams; align CMC plans with regulatory requirements and business objectives.
- Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management.
- Assess regulatory risks; develop mitigation plans and recommendations.
- Support IND through NDA and post-approval lifecycle management (including expedited pathways where applicable).
- Lead preparation, review, and submission of CMC documentation (INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports, and Health Authority responses).
- Author/review Module 2 and Module 3 CMC documentation.
- Lead CMC regulatory activities for initial marketing applications and registration.
- Serve as primary CMC representative for Health Authority meetings; support inspection readiness.
- Develop post-approval CMC filing strategies (process improvements, formulation changes, specs, analytical changes, site/technology transfers, validation, stability updates, supplier changes).

Technical Leadership:
- Provide regulatory guidance for oral solid dosage forms and modified-release formulations.
- Support formulation/process development, scale-up, technology transfer, process validation, and commercial manufacturing.
- Evaluate regulatory impact of API/excipient/formulation/process/packaging/site changes.
- Provide regulatory oversight for analytical methods, validations, specifications, and stability.
- Assess CMAs/CPPs/CQAs and control strategies across development.
- Provide CMC regulatory support for combination or biologic products when applicable.

Education/Experience Requirements:
- Bachelor’s degree (Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related) required.
- MS/PhD/PharmD or equivalent preferred.
- 7+ years Regulatory Affairs experience in pharma/biotech, including significant CMC Regulatory Affairs.
- Strong small-molecule experience from IND through commercialization and post-approval lifecycle.

Additional Skills/Experience:
- Experience with global regulatory activities (FDA, EMA, GCC, PMDA).
- Experience with Health Authority interactions (CMC topics).
- Ability to manage post-approval CMC changes and complex ownership independently.
- Leadership and stakeholder relationship-building skills.
- Travel ~10% domestically/internationally.
- Not expected to be 100% remote; must be able to do face-to-face/onsite work in San Diego.

Benefits:
- Premium health, financial, work-life and well-being offerings; wellness and employee support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
- Competitive compensation (base pay/short-term incentive and long-term incentive/company stock); target base pay range: $132,000–$172,000.

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