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.