Manager of Regulatory Affairs in Somerset NJ.
Fast growing company with great management team.
Good writing and communication skills are required
CMC experience required
Experience with ANDA/IND/NDA preferred
Experience with eCTD submissions
Annual reports in accordance FDA and ICH guidelines
Knowledge and experience of pharmaceutical regulations and cGMP are highly desired
Min BS degree. MS degree a plus! Flexibility for WFH possible for the right candidate.
Great Benefits and opportunity for advancement!