Senior Regulatory Labeling Manager
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
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