Sr. Regulatory Affairs Manager – Boulder, CO 80301

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Responsibilities:

The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations.
The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and / or Ethics Committees, as applicable.
The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams,…
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