Senior Manager, CMC Regulatory Affairs
Company: VirtualVocations
Location: Jackson Heights
Posted on: February 4, 2025
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Job Description:
A company is looking for a Senior Manager, Global Regulatory
Affairs - CMC.
Key Responsibilities
Assist with CMC regulatory submission strategies and manage key
regulatory CMC activities
Communicate and coordinate with functional groups to prepare
required CMC documentation for regulatory submissions
Act as regulatory CMC representative on project teams, ensuring
compliance with regulatory requirements
Required Qualifications, Training, and Education
Bachelor's degree in a scientific field; advanced degree is
desirable
6-10 years of experience in the biotechnology industry, with 4-5
years in Regulatory Affairs CMC
Background in vaccine development and knowledge of the vaccine drug
product development process
Experience with aseptically filled drug products and current
GMPs
Familiarity with CTD format and content
Keywords: VirtualVocations, Hempstead , Senior Manager, CMC Regulatory Affairs, Executive , Jackson Heights, New York
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