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Check out JobsAI Director, Regulatory Affairs - Labeling
Company Name
Olema Oncology
Job Overview
As Director, Regulatory Labeling, you will lead the development of labeling for clinical supplies and commercial labeling materials for Olema products. Requires understanding of global labeling requirements and platforms to manage label implementation. Work with Regulatory Affairs, Clinical Development, Clinical Supply, Quality Assurance, and CMC teams, as well as external vendors, to ensure quality control.
Responsibilities:
- Overseeing clinical supply labeling
- Developing labeling processes
- Maintaining labeling documents
- Supporting responses to Health Authority queries
Requirements:
- Bachelor's degree
- 10+ years of relevant experience