Job Description
- *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 (