Manager, CMC Regulatory Affairs at Regeneron in Tokyo

Manager, CMC Regulatory Affairs

Location: Tokyo · Hybrid

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, Japan

Work model: Hybrid

Discover 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 accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.