Senior Manager, Regulatory Affairs

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: