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Senior Regulatory Labeling Manager
Job Summary
A company is looking for a Senior Manager, Regulatory Labeling.
Key Responsibilities
- Manage the Regulatory labeling process throughout the product lifecycle
- Lead the Labeling Working Group and oversee the development, review, approval, and maintenance of various labeling documents
- Provide labeling expertise and prepare submission-ready labeling documents while monitoring worldwide regulation changes
Required Qualifications
- Bachelor's degree in Life Sciences; advanced degree preferred
- 3-4+ years of related Biotech or Pharma industry experience, with 2+ years in labeling
- In-depth knowledge of the labeling process and drug development
- Familiarity with regulatory policies and procedures
- Expert knowledge of FDA, EMA, and international labeling regulations
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COMPLETE JOB DESCRIPTION
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Company Overview
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