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Director, Regulatory Strategy
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Full-time
- We are seeking an experienced Director, Regulatory Strategy who will be responsible for leading the overall regulatory strategy and direction of drug development opportunities and coordinates team tactics, priorities, resources to systematically build and execute complete development plans that align with client business strategies.
- The director leads the regulatory strategy team in delivering a world-class client experience by creating and supporting a client-oriented service that provides advice and counsel to Sponsors.
- The Director will lead preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs. The Director may also serve as Interim Head of Regulatory Affairs for assigned clients/projects.
- They will supervise regulatory scientists and managers to build the talent and skills needed for success, while delivering world-class client service to all new clients and drive revenue performance through retaining clients.
- Knowledge and skills at a level normally acquired through the completion of a Master's or Ph. D. in a scientific or life sciences field;
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