Analyst, Regulatory

Zydus Pharmaceuticals USA Inc. (Pennington, NJ) seeks Regulatory Analyst to Prepare, review and finalize documents for regulatory applications for submission to the USFDA. Prepare and submit Field Alert Reports to the FDA. Track & follow up with OGD for submitted Controlled Correspondence(s), protocol(s), Bio-IND, & Meeting Request(s). Handle Product Complaints by coordination with 3 PL Service provider and the manufacturing locations. Maintain track of patent amendments and Follow up with IP for litigation status and 45 days' notice period. Coordinate with the PV department for collecting data for ICSR and filling to FDA. Participate in building, implementation, maintenance of REMS for product with potential adverse health consequences and ensure stakeholder compliance to the REMS requirement as mandated by the USFDA. Supervise the processing of document entry into the Client document systems. Mail resume to HRD, Zydus Pharmaceuticals USA Inc., 73 Rt. 31 North, Pennington, NJ 08534

Current Openings for Analyst, Regulatory Jobs at Zydus Pharmaceuticals