Offer summary
Qualifications:
Bachelor's Degree in scientific discipline required, Advanced degree (Masters, Pharm.D., or Ph.D.) preferred, 7+ years of pharmaceutical industry experience, 4+ years of regulatory affairs experience, Experience with US and ex-US labeling preferred.
Key responsabilities:
- Provide leadership on product labeling strategies
- Manage the preparation and implementation of regulatory documents
- Lead cross-functional teams through FDA/CHMP discussions
- Ensure compliance with regulations and labeling guidelines
- Establish processes and best practices for labeling