Minimum 10 years pharmaceutical industry experience
5 years japan regulatory lead experience
Experience with small molecules and biologics
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BeOne Medicines is seeking a Senior Manager - Associate Director of Regulatory Affairs in Japan. The successful candidate will oversee regulatory strategies for drug development and market access while managing a team and liaising with regulatory authorities.
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Job Summary
The role involves developing and advising on Japan regulatory strategies to secure market access for innovative oncology treatments.
Candidates must manage the full lifecycle of drug development from clinical trials to post-approval while interfacing with Japan Health Authorities.
BeOne Medicines offers a competitive compensation package including performance-based bonuses, company shares, and extensive learning opportunities.
Matching Summary
Match Score: 75
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BeOne Medicines is seeking a Senior Manager - Associate Director of Regulatory Affairs in Japan. The successful candidate will oversee regulatory strategies for drug development and market access while managing a team and liaising with regulatory authorities.
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Salary
Market competitive compensation; Performance-based annual bonus scheme; Generous welcome grant and performance-based annual equity plan
Skills & Requirements
Must-have
Minimum 10 years pharmaceutical industry experience
5 years Japan regulatory lead experience
Experience with small molecules and biologics
Expertise in CTN, NDA, and BLA/MAA submissions
Fluency in Japanese and English regulatory documentation
Nice-to-have
Strategic creativity in addressing market challenges
Strong negotiation skills with health authorities
Ability to foster a goal-oriented culture
Experience in cross-functional team leadership
Proven track record of significant regulatory accomplishments
Key Requirements
Minimum 10 years in biotech/pharma industry
Minimum 5 years as Japan regulatory lead
Experience with both small molecules and biologics
Thorough understanding of Japan regulatory requirements
Excellent written and oral communication in Japanese and English