Regulatory Affairs Specialist
AustarPharma LLC in Edison, NJ is seeking a Regulatory Affairs Specialist: MS in Pharmaceutics, Pharmaceutical Chemistry or closely related fields with at least 1 year of experience in collecting and reviewing technical CMC documents, reviewing clinical study protocols and reports, and providing guidance to ANDA R&D departments for FDA and cGMP compliance. Experience in drug development with solid dosage form, drug analysis, drug delivery and clinical trial design is also required.
Web Id: 95074
AustarPharma LLC
Newwark, NJ