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Director Regulatory Innovative Medicine - Dossier Project Manager
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- The Regulatory Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers.
- This role will lead multidisciplinary Product Submission Teams where they will manage regulatory document planning, establish dossier timelines, identify and expedite critical path deliverables, and orchestrate hand-offs to Regulatory Operations or the local International Market RA teams.
- Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management.
- Education Preferred: Ph. D or Masters in relevant discipline, or professional degree (eg, Project Management Professional (PMP), DVM, DDS, MD, PharmD).
- Minimum of 5 years in a related position in regulatory affairs project management (creating, filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA).
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