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About the Role

Support regulatory CMC strategy and submissions 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.

Responsibilities

• Support planning, scientific writing, and critical review of CTN, J-NDA, and eCTD supplement submissions.
• Prepare Japanese application forms and regulatory dossiers for high-quality submissions.
• Support regulatory decision-making with cross-functional teams based on local requirements.
• 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 for investigational product release requests.
• Monitor project timelines to support on-time regulatory submissions.

Requirements

• Bachelor's degree in a scientific discipline; Master's degree preferred.
• Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls (CMC) background.
• 10+ years of regulatory CMC experience, including health authority interactions, major submissions, and approvals in Japan.
• Experience supporting CTN, J-NDA, eCTD submissions, PCA, MCN, and PMDA responses.
• Knowledge of Japanese regulatory requirements, guidance documents, and regulatory resources.
• Experience participating in agency meetings and supporting regulatory communications.
• 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 contribute strategically.
• Strong work ethic with the ability to collaborate across teams and apply lessons learned.

Skills

• Japanese
• English
• Regulatory CMC
• CTN
• J-NDA
• eCTD
• PCA
• MCN
• PMDA

Location

• Tokyo, Japan

Work Type

• Hybrid

Experience Level

• Associate Manager
• 10+ years

Education Level

• Bachelor's degree
• Master's degree

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.

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.