Category: Employment General Employment Source: NMG Classifieds Listed: Fri Oct 25th
Regulatory Affairs Associate qualified w/ master's or foreign equiv deg in Chemistry or Pharmacy & 6 mos of work exp to Prep complex submissions (i.e. DMF's & ANDA's in eCTD format) to various governmental agencies & ensure contents are in compliance w/ domestic & int'l regulatory reqmts. Review of Analytical procedures, Analytical validation reports & Certificates of analysis as per respective specification & stability data. Compile regulatory submissions through coord'n w/ other depts & research of internal documentation, complete applications & forms, compose cover letters & summaries & assemble/format submissions in such a manner to facilitate the review process. Prep'n, review & approval of std operation procedures & ensure the compliance of procedures in Qlty control & mfg areas. Aspiring candidates should mail resumes to HR Mgr, Apicore, LLC., 148 Princeton Hightstown Rd, East Windsor, NJ 08520. Job Loc: East Windsor, NJ.