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Years of Experience
Date Last Verified
ProfileDirector, Regulatory Affairs Strategy Responsibilities: Regulatory Knowledge: Maintains a high level of regulatory knowledge and provides regulatory advice. Agency Interactions: Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor. 3. Dossier Submissions: Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions. Registration Strategy: Leads the formulation of registration strategies for products/projects. Ensures US and/or EU registration strategies are designed and captured in the Global Regulatory Affairs Strategy Plan and ensures implementation of the strategy. Ensures registration strategies adhere to corporate objectives. Team Interactions: Provides regulatory affairs representation on project teams; may lead regulatory sub-teams. May act as single point of RA contact on cross-functional teams; fosters a global view as a member of the development team. People Management: Mentors and provides guidance to junior RA representatives in a matrix environment.
Qualification and Experience
Qualifications: Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.) with preference for M.D. and Ph.D. JD Degree with appropriate regulatory experience would be considered. Experience in the pharmaceutical industry (8-10 years), including direct oncology regulatory affairs with the FDA preferred. Experience with ex-US regulatory authorities is a plus.
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