Regulatory Affairs Manager
Company: VirtualVocations
Location: Gary
Posted on: April 5, 2025
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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, Racine , Regulatory Affairs Manager, Executive , Gary, Wisconsin
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