Associate Director, CMC Regulatory Affairs - Biologics
$150,000–$195,000 year
HybridSan Diego, California, United States
Job Summary
Develop and execute global CMC regulatory strategies supporting clinical development, registration, and lifecycle management of biologic products. Serve as the primary CMC Regulatory lead on cross-functional program teams, partnering with Technical Operations, Manufacturing, Quality, and Supply Chain to align CMC activities with regulatory objectives. Lead preparation, review, and submission of CMC content for global filings including INDs, IMPDs/CTAs, BLAs/NDAs, and MAAs, while authoring Module 2 and Module 3 content. Independently manage Health Authority interactions, assess regulatory risks, and drive inspection readiness for late-stage development and rare disease therapeutics. Requires 8+ years of Regulatory Affairs experience within biologics and the ability to travel 10% domestically and internationally.
Required Qualifications
- Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
- 8+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry
- significant CMC Regulatory Affairs experience
- Strong technical expertise in biologics drug development programs from development through commercialization
- 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
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