Role :
Director, Regulatory Affairs
Bay Area - Hybrid
Company Description :
This is a leading cell therapy CART biotech developing treatments for chronic autoimmune disorders. After four Investigational New Drug (IND) milestones in the past year alone, the team is expecting significant clinical activity, and an explosive hiring period across the Regulatory, Quality, CMC, and Clinical groups.
If you thrive in an innovative and fast-paced environment, this is the place for you. They put their money where their mouth is, their Regulatory success over the last 12 months being the prime example.
Role Description :
As the Regulatory Affairs Director, you will have the opportunity to lead Allogeneic trials the most innovative in history! This role allows you to bring past Regulatory knowledge to the table, while also be creative in strategic discussions and decisions.
The role will be Globally facing, as the company expands its targets. Your hiring manager is a one of the most personable in the field, always bringing a smile to each and every call.
They know when to have fun and know when it’s time to be serious.
Qualifications :
Bachelor’s Degree in a Life Sciences sector. Advanced degree preferred but not required.
10+ years of Regulatory Affairs experience within a pharmaceutical or biotech setting.
Experience with Cell Therapy or Gene Therapy programs is required.
Prior experience with IND / CTA, and BLA / MAA submissions, strong knowledge of global regulations
Previous experience in a small company setting.
If you are interested in this position, please apply here or sent me an email at [email protected]
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