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Job Description:
General Description:
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. The individual will provide support to cross-functional teams on CMC regulatory strategies.
Essential Functions of the Job:
Manages both small molecule and biologics products (Also new modality if applicable).
In collaboration with Global regulatory CMC teams, develop and implement Japan regulatory CMC related submission strategies and timeline; work collaboratively with cross-functional teams and communicate Japan strategies and timeline as needed.
Conduct regulatory risk assessment, lead to identify key regulatory CMC issues and mitigation...