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Senior Manager, Regulatory Affairs - Cell Therapies
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- Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next-generation technology for cellular therapy.
- The successful candidate should possess a scientific background and will have an understanding of the unique aspects of cell therapy.
- Work under the director of the RA Director to craft the health authority engagement strategy and interaction plan, drive the formulation of the meeting package, lead the team through meeting rehearsals (if needed) and may moderate the meeting itself.
- Submission types can vary, may include: Investigational New Drug (IND) applications, Biological License Applications (BLA), Regenerative Medicine for Advanced Therapy (RMAT) Applications, Investigational Device Exemption (IDE), 510(k), and other submissions as necessary.
- 2+ years of experience in Cell Therapy.
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