Title: Senior Manager, Global Regulatory Affairs, Labeling
Location: REMOTE (EST)
Summary: A global, patient focused pharmaceutical company is looking for a dynamic and driven regulatory labeling professional to come join their regulatory affairs team. This innovative company focuses in both oncology and neurology, and is looking for a Senior Manager, Global Regulatory Labeling to function as a leader cross functionally, facilitating and leading the end-to-end labeling process for multiple products.
The Senior Manager, Global Regulatory Labeling will be responsible for:
- Leading and facilitating the development, review, approval and maintenance of Company Core Data Sheets (CCDS) and Country Product Information (CPI)
- Acting as Subject Matter Expert (SME) on both local and global regulatory labeling requirements.
- Providing tactical and strategic guidance to CPI development teams, as well as managing direct reports
- Maintain expertise in key labeling guidelines, regulations, and requirements worldwide, as well as maintaining labeling history documents.
The Senior Manager, Global Regulatory Labeling should have the following qualifications:
- BS required, higher degree in life sciences preferred
- 8+ years of experience in pharmaceutical/biotech industry and at least 3-5 years of regulatory experience
- Experience with global and/or US regulatory labeling
- Solid working knowledge of global regulations in drug development, as well as knowledge in FDA and EU labeling regulations.
- A team player with strong communication skills, project management skills, and strategic thinking.
If you are interested in the Senior Manager, Global Regulatory Labeling role, then please don't wait to apply.