Senior Manager, Regulatory Affairs

Regeneron · Tokyo

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RegulatoryFull-timeCompany career page

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What they're looking for

Bachelor's degree in scientific discipline; Master's degree preferred
10+ years pharmaceutical industry experience; 5+ years regulatory affairs experience
Demonstrated experience managing health authority interactions and major submissions in Japan
Deep knowledge of Japan submission requirements, local regulations, and regulatory standards
Knowledge of clinical trial requirements and ability to resolve local procedural challenges
Fluent in Japanese and English languages
Strategic thinking, commercial awareness, and strong written and verbal communication skills

What you'll be doing

Plan and execute Japan regulatory strategies and PMDA consultations for assigned programs
Lead marketing applications and post-approval change submissions to regulatory authorities
Manage interactions with PMDA and other Japanese health authorities
Lead or support clinical trial notification preparation and submission activities
Represent Regulatory Affairs across clinical, commercial, medical, and patient safety teams

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RoleLantern checked active

RoleLantern checkedNeeds clarity

Date posted4 days ago

Last source check1 day ago

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