Manager, CMC Regulatory Affairs
Build our future together:At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs to join our Regulatory Affairs team, supporting our Japan organization in a hybrid work mode. In this role, you will lead regulatory CMC activities across therapeutic areas while collaborating with Global Regulatory CMC, CMC Regulatory Science, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.When & where:Location: Tokyo, JapanWork model: HybridDiscover your role:Lead planning, scientific writing, and critical review of CTN, J-NDA, and eCTD supplement submissions.Prepare Japanese application forms and support high-quality regulatory dossiers.Drive regulatory decisions based on requirements while working across cross-functional teams.Act as a local liaison with PMDA for CMC submissions and information requests.Assess CMC change controls against regulatory filings to maintain compliance.Review manufacturing processes and specifications against approved filings.Participate in agency meetings and communicate regulatory positions and feedback.You navigate ambiguity confidently and build effective partnerships across teams.This role requires:Bachelor's degree in a scientific discipline; Master's degree preferred.Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls (CMC) background.15+ years of regulatory CMC experience, including health authority interactions, major submissions, and approvals in Japan.Experience leading CTN, J-NDA, eCTD submissions, PCA, MCN, and PMDA responses.Deep knowledge of Japanese regulatory requirements, guidance documents, and regulatory resources.Experience managing submission timelines and delivering filings on schedule.Ability to obtain and maintain Foreign Manufacturing Accreditation or Foreign Manufacture Registration.High fluency in Japanese and English.Ability to interpret regulations, communicate effectively, and think strategically.Strong work ethic with proven collaboration across diverse teams.Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable a...