Regulatory Affairs Manager
Newark Metro Area, NJ
Participate in the preparation of regulatory submissions and manage related requirements and timelines. The incumbent will interact closely with a range of internal and external partners including Regulatory Operations, Clinical Operation, Contract Research Organization (CRO), and Clinical Supply on a range of regulatory activities related to clinical studies.
Requirements - BS or advanced degree with 5-7 years in Regulatory Affairs supporting clinical submissions
Contributes to preparation of high-quality regulatory submissions by helping to organize cross-functional activities pertaining to the regulatory function, including the development of meeting requests, timelines, and compilation of briefing documents intended for submission to regulatory authorities
Works with CROs, reviews and approves regulatory packages. Informs clinical supply for IMP release. Compiles Investigator CV and Form 1572 for FDA submission.
Liaises with external CROs and other vendors to support external safety data processing.
Drafts cover letter and FDA forms for Investigator submissions to FDA.
Ensures compliant documentation is received prior to release of drug supplies.
Ensures compliance and availability of documentation during QA and FDA audits as required.