Sr/Director, Regulatory Affairs | REMOTE | Pre-IPO
ā¢ *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.
ā¢ *Must haves**
(we cannot consider without all of these):
ā¢ Minimum 8 years life science experience, 6+ years in RA
ā¢ Masters Degree or above (higher priority for advanced degrees)
ā¢ Prepared/lead agency meetings
ā¢ Developed/completed pre-IND/IND submissions (strong preference for NDA/BLA as well)
ā¢ Late stage/pivatal redistration studies
ā¢ EU CTR
ā¢ Strong background in a majority of these areas: pre-IND, EOP1, EOP2, IND, CTA, IMPD, NDA, orphan designations, fast track, and breakthrough designation filings
ā¢ Recent experience working within small biotech (
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.
ā¢ *Must haves**
(we cannot consider without all of these):
ā¢ Minimum 8 years life science experience, 6+ years in RA
ā¢ Masters Degree or above (higher priority for advanced degrees)
ā¢ Prepared/lead agency meetings
ā¢ Developed/completed pre-IND/IND submissions (strong preference for NDA/BLA as well)
ā¢ Late stage/pivatal redistration studies
ā¢ EU CTR
ā¢ Strong background in a majority of these areas: pre-IND, EOP1, EOP2, IND, CTA, IMPD, NDA, orphan designations, fast track, and breakthrough designation filings
ā¢ Recent experience working within small biotech (