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Check out JobsAI Director, Regulatory Affairs - Labeling
Company Name: Olema Oncology
Job Overview
The Director, Regulatory Labeling will lead the development of labeling for clinical supplies and commercial labeling materials for Olema products. This role requires a strong understanding of global labeling requirements and will work closely with:
- Regulatory Affairs
- Clinical Development
- Clinical Supply
- Quality Assurance
- CMC teams
- External vendors
Responsibilities
- Overseeing labeling processes
- Developing SOPs
- Maintaining labeling documents
- Supporting responses to Health Authority queries
Requirements
- Bachelor's degree
- 10+ years of relevant experience