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Regulatory Affairs Manager

Company: VirtualVocations
Location: Gary
Posted on: April 5, 2025

Job Description:

A company is looking for a Regulatory Affairs Manager CMC.
Key Responsibilities

Generate and execute global and country-specific regulatory strategies
Provide CMC regulatory strategy for assigned projects, including submission strategy and regulatory risk assessments
Develop global dossiers for CMC content for initial submissions, variations, and amendments

Required Qualifications

Doctorate degree, or Master's degree with 3 years of related experience, or Bachelor's degree with 5 years of related experience, or Associate's degree with 10 years of related experience, or High school diploma/GED with 12 years of related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience

Keywords: VirtualVocations, Skokie , Regulatory Affairs Manager, Executive , Gary, Illinois

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