Regulatory Affairs Specialist

AMNEAL PHARMACEUTICALS
Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. This includes, but is not limited, to New Drug Application (NDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Post-Approval Supplements, Annual Reports (AR), and Periodic Adverse Drug Experience Reports (PADERs). The incumbent serves as regulatory lead on cross functional teams including Clinical, CMC, Quality, and Marketing. Assists in tracking project timeliness and follows up cross functionally for required documents.

Coordinates with external vendors, contractors and consultants for project support activities. Assists in organizing meetings with FDA including compilation of meeting requests and briefing packages with cross functiona...