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Associate Director/Director Regulatory Affairs Generalist

People With Chemistry

Posted on: 14 Mar 2024

Job Location: Redwood City, US

Job Description:

Associate Director / Director, Regulatory Generalist

Hybrid Role - 3 Days in Menlo Park, CA

Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Generalist to join their team. This position will be reporting into the VP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Our client recently reported positive P3 data for their lead drug candidate and is in the process of filing for an NDA this year.

Key Responsibilities:

Carry out Reg Affairs and Reg CMC functions to support major Regulatory submissions
Serve as a cross-functional leader within the organization to facilitate prompt and accurate regulatory documentation

Key Qualifications/Requirements

9+ years of Regulatory Affairs (mix of Clinical Reg and Reg CMC highly preferred)
NDA/late stage experience highly preferred
Small molecule development experience required
Startup experience highly preferred

Please feel free to reach out directly to Ryan Moran to learn more:

[email protected]

Apply

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