Sr/Director, Regulatory Affairs | REMOTE | Pre-IPO

• *SR/DIRECTOR, REGULATORY AFFAIRS**

Very late clinical stage biotechnology client focused 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 all of these):
• Minimum 8 years life science experience, 6+ years in RA
• Masters Degree or above (higher priority for advanced degrees)
• Prepared/lead agency meetings
• Developed/completed pre-IND/IND submissions (strong preference for NDA/BLA as well)
• Late stage/pivatal redistration studies
• EU CTR
• Strong background in a majority of these areas: pre-IND, EOP1, EOP2, IND, CTA, IMPD, NDA, orphan designations, fast track, and breakthrough designation filings
• Recent experience working within 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.