My client is seeking a Director, Regulatory Affairs to join their Regulatory team.
Responsibilities
- Lead and manager IND enabling activities
- Ability to be independent and debate
- Be able to prepare nd lead successful regulatory meetings and major health authority interactions
Requirements
- At least 8-10+ years of Regulatory Affairs experience
- Advanced scientific degree preferred
- Extensive global pediatric, Orphan Drug, Fast Track and Breakthrough Therapy experience
- Extensive global regulatory submission experience (IND/CTA/BLA/NDA
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