Associate Director, Global Regulatory Affairs Labeling
Company Summary:
My client, a growing global biopharmaceutical company, is focused on the discovery and development of treatments for unmet needs in oncology and dermatology. They are looking to add a Global Regulatory Affairs Labeling Associate Director to their team on a hybrid basis to their site in Wilmington, DE!
The Global Regulatory Affairs Labeling Associate Director will be responsible for:
- Creating, updating and maintaining labeling documents throughout the product lifecycle.
- Leading cross-functional teams in development, revision, review and approval of Company Core Data Sheet and product labeling documents for assigned products.
- Providing labeling expertise/guidance to teams about labeling content, processes and timelines.
- Serving as the point of contact on Global Regulatory sub-teams to ensure delivery of labeling documents meet quality, compliance and regulatory standards.
The Global Regulatory Affairs Labeling Associate Director should have the following qualifications:
- Bachelor's degree and 4+ years of direct regulatory labeling experience in the pharmaceutical industry.
- US regulatory labeling experience is required.
- Ex-US regulatory labeling experience is a plus.
- Ability to guide cross-functional teams and drive consensus on labeling issues.
