Associate Director of Regulatory Affairs, CMC

Accountabilities:: Serve as a primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions, including BLAs, MAAs, IMPDs, INDs, amendments, supplements, and related filings. Author and review scientifically rigorous Module 3/CTD content covering drug substance, drug product, analytical development, manufacturing, and related CMC areas. Support commercial lifecycle management activities, including post-approval submissions, CMC supplements, comparability protocols, manufacturing changes, labeling updates, and annual product reports. Contribute to international regulatory submissions, particularly EMA and ANVISA filings, ensuring content meets jurisdiction-specific requirements. Prepare and coordinate health authority interactions, including FDA Type A/B/C meetings, EMA Scientific Advice requests, and formal interactions with other global agencies. Develop meeting briefing documents, presentations, written responses, and other materials required for regulatory discussions and agency questions. Partner with Process Development, Analytical Development, Manufacturing, Quality, and Clinical teams to provide CMC regulatory guidance on late-stage development activities and study design. Support regulatory strategies related to process characterization and validation, comparability, analytical method validation, stability programs, scale-up, and technology transfer. Prepare clear and comprehensive responses to health authority questions, deficiency letters, and requests for additional information across U.S. and international jurisdictions. Monitor evolving global CMC regulations and cell and gene therapy guidance, contributing to regulatory intelligence and internal best-practice initiatives. Track regulatory commitments, submission timelines, annual reporting requirements, and post-approval obligations to ensure timely and compliant execution. Provide informal mentorship to junior regulatory professionals and contribute to the development of regulatory capabilities as the organization grows. Requirements Bachelor’s degree in life sciences, chemistry, biochemistry, or a related discipline is required; an MS, PhD, PharmD, or equivalent advanced degree is preferred. At least 7 years of regulatory CMC experience within the biopharmaceutical industry, including 3–5 years of direct, hands-on experience in cell therapy. Experience with allogeneic and/or autologous cell therapy platforms is required; experience across both is an advantage. Demonstrated late-stage and/or commercial CMC regulatory experience, with strong BLA and/or MAA submission experience highly preferred. Proven ability to independently author, review, and edit CMC regulatory submissions, particularly Module 3/CTD content, with minimal supervision. Hands-on experience with CMC lifecycle management, including post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reporting. Strong understanding of late-stage and commercial CMC operations, including process characterization and validation, analytical method validation, stability study design, scale-up, and technology transfer. Experience preparing and submitting regulatory dossiers outside the United States, with specific experience interacting with EMA and ANVISA required. Familiarity with additional global health authorities such as Health Canada or PMDA is a plus. Experience supporting formal FDA, EMA, and/or ANVISA health authority meetings, including meeting requests, briefing packages, presentations, and agency responses. Strong knowledge of global CMC regulations and guidelines applicable to biologics and cell and gene therapies, including FDA regulations, EMA guidance, ICH Q5–Q12 guidelines, and relevant international requirements. Exceptional scientific and regulatory writing skills, with demonstrated ability to produce accurate, clear, well-structured documentation to high editorial standards. Strong organizational skills and attention to detail, with the ability to manage multiple complex priorities and deadlines in a fast-paced environment. Excellent collaboration and communication skills, with the ability to partner effectively across Quality, Process Development, Manufacturing, Clinical, and CMC leadership functions. Comfortable working independently and contributing as a senior individual contributor without direct reports. Ability and willingness to provide mentorship and support the development of junior regulatory team members. San Diego, California is preferred, though highly qualified remote candidates within the United States will be considered. Benefits Base salary of $185,000–$200,000 USD , with exact compensation determined based on level, skills, experience, and other relevant factors. Fully remote work opportunity within the United States. Comprehensive medical, dental, and vision coverage. Group life insurance. Long-term disability (LTD) coverage. 401(k) retirement plan. Employee Assistance Program (EAP). Flexible Spending Account (FSA). Paid time off (PTO). Company-paid holidays, including a year-end holiday week. Employee recognition program with rewards that can be exchanged for selected items and experiences. Collaborative, entrepreneurial, and innovative work environment. Opportunity to contribute to late-stage development, commercial launch, and global regulatory strategy for cell therapy programs. Senior-level exposure to global health authorities and cross-functional biotechnology development teams.