Associate Director of Regulatory Affairs, CMC

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the primary author and lead reviewer for CMC sections in late-stage and commercial regulatory submissions, including BLAs, MAAs, IMPDs, INDs, amendments, and supplements.

• Create scientifically robust Module 3/CTD dossier content that encompasses drug substance, drug product, and analytical sections.

• Assist in managing the commercial lifecycle, which includes post-approval submissions, comparability protocols, CMC supplements, labeling updates, and annual product reviews.

• Contribute to submissions outside the US, particularly for EMA and ANVISA filings.

• Prepare and organize meeting packages, briefing documents, slide presentations, and written responses for FDA, EMA, and other health authorities.

• Offer regulatory input related to CMC, including process characterization, comparability studies, analytical method validation, and stability programs.

• Compile, organize, and draft regulatory documents and responses to inquiries and deficiency letters from health authorities.

• Stay updated on global CMC regulations and guidance for cell and gene therapies.

• Participate in regulatory intelligence and best practices initiatives.

• Monitor regulatory commitments, submission timelines, annual reporting, and post-approval reporting requirements.

• Collaborate across functions with Quality, Process Development, Manufacturing, Analytical Development, Clinical, and CMC leadership teams.

• Provide informal mentorship and assist in the development of junior regulatory staff.

⛳️ Requirements

• Bachelor's degree in life sciences, chemistry, biochemistry, or a related discipline is required.

• A minimum of 7 years of regulatory CMC experience in the biopharmaceutical sector.

• At least 3-5 years of direct, hands-on experience in cell therapy (both allogeneic and/or autologous).

• Experience in late-stage and/or commercial CMC regulatory processes.

• Proven experience with BLA and/or MAA submissions is strongly preferred.

• Independent authorship of CMC regulatory submissions, including Module 3/CTD, is essential.

• Practical experience in lifecycle management CMC activities, such as post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reports.

• Familiarity with late-stage and commercial CMC operations and development processes, including process characterization and validation, analytical method validation, stability study design, and scale-up/tech transfer.

• Experience with regulatory submissions outside the US, specifically with EMA and ANVISA.

• Background in supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA.

• Strong understanding of global CMC regulations and guidelines relevant to biologics and cell/gene therapy, including FDA regulations (21 CFR), EMA guidelines, ICH Q5-Q12 series, and other international requirements.

• Excellent written communication skills with the ability to independently author, review, and edit regulatory documents.

• Strong organizational skills and attention to detail; capable of managing multiple priorities and deadlines.

• Proficient in collaborating across functions with Quality, Process Development, Manufacturing, Clinical, and CMC leadership teams.

• Ability to provide informal mentorship and support the development of junior regulatory staff.

• Preferred location is San Diego, CA; however, highly qualified remote candidates will be considered.

🏝️ Benefits

• A beautiful facility.

• An entrepreneurial, highly collaborative, and innovative work environment.

• 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 week off during the year-end holiday season.

• Bonus.ly recognition program where points can be exchanged for desired items.