Senior Manager, CMC Regulatory Affairs

Company: VirtualVocations
Location: Jackson Heights
Posted on: February 4, 2025

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, New Haven , Senior Manager, CMC Regulatory Affairs, Executive , Jackson Heights, Connecticut

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