Senior Manager to Associate Director, Regulatory CMC

BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet the aggressive timelines.

Requirements

• Manages both small molecule and biologics products
• Develops and implements Japan regulatory CMC related submission strategies and timeline
• Conducts regulatory risk assessment and leads to identify key regulatory CMC issues and mitigation activities
• Prepares Japan regulatory CMC related documents
• Manages manufacturing license including foreign manufacturer accreditation for Japan products
• Supports Reg CMC interaction with PMDA and supports inspection
• Supports the development of Japan CMC dossier template for both CTN and NDA/BLA

Benefits

• Market competitive compensation package
• Company shares
• In-house and external learning and development opportunities
• Fantastic benefits program