Senior Manager of Regulatory Affairs
Company: VirtualVocations
Location: Vista
Posted on: May 5, 2025
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Job Description:
A company is looking for a Senior Manager, Regulatory
Affairs.
Key Responsibilities
Manage regional regulatory activities as part of the Global
Regulatory Team
Lead the preparation and coordination of US regulatory submissions
and responses to health authority information requests
Review nonclinical, clinical, and CMC documentation, contributing
to content as needed
Required Qualifications
B.S. degree, preferably in a scientific discipline
4 years of experience in the biopharmaceutical or pharmaceutical
industry, with a focus on regulatory affairs
Experience with electronic regulatory submissions and regulatory
templates
Solid understanding of FDA and ICH regulations related to clinical
research and product development
Familiarity with EU Clinical Trial Regulation and ROW country
regulatory requirements is a plus
Keywords: VirtualVocations, Colton , Senior Manager of Regulatory Affairs, Executive , Vista, California
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