Senior Manager or Associate Director, Lifecycle RA
BeOne Medicines(3 months ago)
About this role
Local Representative for Regulatory Affairs and Compliance in Japan at BeOne, responsible for providing leadership and strategic direction for post-marketing regulatory activities and serving as an internal consultant on Japanese pharmaceutical law (PMD Act). The role ensures regulatory compliance systems, licensing, labeling maintenance, and inspection readiness while aligning regional requirements with global regulatory strategy.
Required Skills
- Regulatory Affairs
- Compliance
- Labeling
- SOPs
- Auditing
- GMP Inspections
- CMC Variations
- Stakeholder Management
- Risk Management
- Communication
Qualifications
- Bachelor Degree in Pharmacy or Life Science
- Master Degree in Pharmacy or Life Science
About BeOne Medicines
beonemedicines.comBeOne Medicines, formerly BeiGene, is committed to developing innovative cancer medicines by partnering globally to serve patients everywhere.
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