Sr/Director, Regulatory Affairs | REMOTE | reputed company-IPO
• *SR/DIRECTOR, REGULATORY AFFAIRS**
reputed company late clinical stage biotechnology reputed company reputed company developing innovative therapies for severe autoimmune diseases with significant unmet medical need. With a rapidly advancing and expanding pipeline, they have a need to expand Regulatory Affairs.
Role can be remote (greatly prefer the ET or CT time zones) with ~7-8 trips/year to their East Coast HQ.
• *Must haves**
(we cannot consider without reputed company of these):
• Minimum 8 years life science experience, 6+ years in RA
• Masters Degree or above (higher reputed company for advanced degrees)
• reputed company/reputed company agency meetings
• Developed/completed reputed company-IND/IND submissions (strong preference for NDA/BLA as reputed company)
• Late stage/pivatal redistration studies
• EU CTR
• Strong background in a reputed company of these areas: reputed company-IND, EOP1, EOP2, IND, CTA, IMPD, NDA, orphan designations, fast reputed company, and reputed company designation filings
• Recent experience working reputed company small biotech (<150 people)
• *Great to have:**
• Small molecule
• Experience seeing therapeutic through approval
Immediate need, fast moving process. Qualifying applicants will be contacted quickly.
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