Sr. Regulatory Affairs Specialist (2 x openings) in Piscataway, NJ
Prepare and review regulatory submissions for domestic or international drug products in eCTD format. Work with manufacturing and R&D to ensure that products are developed and produced according to applicable regulations and standards. Handle all correspondences from FDA like deficiencies, controlled correspondences, information requests, DRL etc. Develop quality metrics and provide quality support to QA team. Monitor associates for regulatory eCTD submissions. Req.: Associate's degree/equiv. in Microbiology, Regulatory Affairs or related, 2 yrs of experience in reviewing and writing regulatory documentation related to drug product safety reports, ANDAs, INDs, NDAs. Familiar with USP/NF, eCTD publishing tools, SPL, DMF, US regulatory submissions (ANDA, NDA, INDs etc) and FDA/ICH regulations related to generic & new drug development in pharmaceutical industry. Send resume to Aucta Pharmaceuticals, Inc. 71 Suttons Ln, Piscataway, NJ 08854