Director of CMC Regulatory Affairs
Company: VirtualVocations
Location: Miami
Posted on: February 1, 2025
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Job Description:
A company is looking for a Director, CMC Regulatory Affairs.
Key Responsibilities
Lead the CMC non-antibody team for cell and gene therapy
technologies and oversee global regulatory strategies
Direct the preparation, review, and submission of regulatory
documents for FDA, EMA, and other authorities
Provide strategic input and oversight for regulatory filings and
interactions with global regulatory authorities
Required Qualifications
Bachelor's degree in a relevant technical or scientific discipline;
advanced degree strongly preferred
Minimum of 10 years of experience in the pharmaceutical/biotech
industry with at least 5 years in CMC Regulatory
Experience in cell and gene therapies is a distinct advantage
At least 3 years of managerial experience
Proven track record with regulatory authorities such as FDA and
EMA
Keywords: VirtualVocations, Kendall West , Director of CMC Regulatory Affairs, Executive , Miami, Florida
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