Description
We're looking for a Manager of Regulatory Affairs , working in Biotechnology / Medical Devices industry in Cambridge, Massachusetts, United States .
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- Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
- Develops detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of products / projects.
- Participates as an active team member of the Global Regulatory Teams for assigned programs and provide strategic regulatory advice to project teams as required.
- Coordinates responses to regulatory authorities questions with strict deadlines.
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