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About the Role

Regeneron is seeking a Manager, CMC Regulatory Affairs to support its Japan organization in a hybrid work mode. This role involves leading regulatory CMC activities across therapeutic areas, collaborating with global teams, and contributing to the development of life-changing medicines.

Responsibilities

• 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.

Requirements

• 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.

Skills

• Regulatory CMC
• CTN submissions
• J-NDA submissions
• eCTD submissions
• PCA
• MCN
• PMDA responses
• Japanese regulatory requirements
• Scientific writing
• Cross-functional collaboration
• Communication
• Strategic thinking

Location

• Tokyo, Japan

Work Type

• Hybrid

Experience Level

• 15+ years

Education Level

• Bachelor's degree
• Master's degree preferred

Benefits

• 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
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We are committed to building a workplace with an inclusive culture.
• We believe we do our best work when we are together.

Equal Opportunity

• 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.