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Regulatory affairs Jobs in San Jose, CA
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Executive Director, Regulatory Affairs
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IntelliPro Group Inc.Sunnyvale, CA, USExecutive Director, Regulatory Affairs
Trebla TalentSunnyvale, CA, United States- Full-time
Role : Senior Director / Executive Director of Regulatory Affairs
Location : Bay Area (Remote - West Coast Preferred)
About the Company :
This late-stage clinical biotech is pioneering a new class of complementary medicines for patients battling neurodegenerative and autoimmune disorders. The company is expanding its regulatory team following groundbreaking positive data from its successful Phase 3 trial.
The Role :
With exciting plans to file its first BLA in 2025, the team is naturally expanding! This ED / SD will report to the Head of Regulatory Affairs and provide strategic regulatory leadership for its upcoming BLA submission and additional NDA / MAA submissions.
- Lead NDA and MAA Regulatory Strategy while supporting the ongoing BLA
- Directly interface with FDA and EMA.
- Make hiring decisions as the Regulatory team expands
What We're Looking For :
If you are interested in the Executive Director of Regulatory Affairs, please reach out to [email protected].