Senior Manager, CMC Regulatory Affairs - Small Molecules
$132,000–$172,000 year
On-siteSan Diego, California, United States
Job Summary
Develop and implement CMC regulatory strategies to support clinical development, registration, and lifecycle management of small molecule pharmaceutical products. Serve as the primary CMC Regulatory lead on cross-functional program teams, partnering with Pharmaceutical Development, Manufacturing, Quality, and Regulatory Operations to ensure alignment of CMC activities with regulatory objectives. Lead preparation, review, and submission of CMC documentation for filings including INDs, CTAs, IMPDs, NDAs, and MAAs, while authoring Module 2 and Module 3 documentation. Provide strategic regulatory guidance for oral solid dosage forms, support Health Authority meetings, and manage post-approval changes such as manufacturing site transfers and specification updates. Requires 7+ years of CMC Regulatory Affairs experience supporting small molecules from IND through commercialization.
Required Qualifications
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline
- 7+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry
- significant CMC Regulatory Affairs experience
- Strong experience with small molecule pharmaceutical products from IND through commercialization and post-approval lifecycle management
- Ability to travel 10% domestically and internationally
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego
- No role is expected to be 100% remote
Desired Qualifications
- Advanced degree (MS, PhD, PharmD, or equivalent) in related discipline
- Demonstrated experience preparing and managing CMC regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, annual reports, and variations
- Experience supporting global regulatory activities with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Gulf Cooperation Council (GCC) regulatory authorities, and Japan's Pharmaceuticals and Medical Devices Agency (PMDA)
- Experience supporting manufacturing process development, formulation development, process validation, technology transfer, and commercialization of small molecule drug products
- Experience leading or supporting Health Authority interactions related to CMC topics
- Demonstrated experience managing post-approval CMC changes, including manufacturing changes, site transfers, specification updates, analytical method changes, supplier changes, and lifecycle management activities
- Ability to work independently and take ownership of complex CMC regulatory activities
- Demonstrated leadership capabilities and ability to build effective relationships with internal and external stakeholders
- Prior biologics experience
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