Senior Manager, Regulatory Affairs
2 weeks ago
Senior Manager, Regulatory Affairs
*Hybrid Role - Menlo Park, CA*
Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their neurology and endocrinology programs.
Key Responsibilities
Manage the preparation of Regulatory filings (IND, CTA, NDA, MAA) and author sections of those documents as needed
Maintain up-to-date knowledge of US and ex-US health authority requirements
Provide support to health authority interactions
Provide input and execute long-term regulatory strategy for assigned programs
Key Qualifications
5+ years of Regulatory Affairs experience
Neurology/Endocrinology experience preferred
Experience supporting programs from P1-P3
Small molecule background preferred
Please reach out to Ryan Moran to learn more:
ryan.moran@peoplewithchemistry.com
#J-18808-Ljbffr
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