Sr. Manager/Associate Director, CMC Regulatory Sciences

Role: Senior Manager / Associate Director, CMC Regulatory Sciences supporting early-stage biopharma development, with focus on drug substance and drug product regulatory strategies. Responsibilities: collaborate with technical teams to design and implement control strategies aligned with ICH/regional requirements; author and review submissions (IND, IMPD, CTA, NDA, MAA), respond to health authority queries; develop and maintain risk assessments for impurities; advise on material selection and process characterization; leverage digital tools to enhance submission quality; interface with global regulatory, development, and manufacturing teams on lifecycle and launch strategies. Requirements: PhD with 7+ years or BS/MS with 10+ years experience; background in CMC development and regulatory authoring, familiarity with FDA, EMA, ICH guidelines; knowledge of analytical methods, cGMP, and global stability requirements; strong communication and project management skills. High-Value: focus on small molecules or biologics, early to late-stage development (IND to post-approval), global submission experience, including complex control strategies, risk assessments, and digital tool integration. Work Setup: hybrid role based in San Francisco or remote, with some regional collaboration.