Amgen Inc.; Manager, Regulatory Affairs; Cambridge, MA: Manage commercial life-cycle of products across regions, which includes serving as sole-decision maker of strategy (10%). Supporting regulatory submissions by conducting regulatory research and developing submission strategy and managing timelines; Ensuring compliance of documents with all applicable laws and regulations; Providing guidance to cross functional teams on regulatory strategy, and manage authoring teams delivering successful regulatory filings/commitment; Developing post approval variations for commercial biologics including maintenance of marketing applications; and Managing tools such as Insight and EDM. Interested candidates send resume to: J. Cummings, 2202 N. Westshore Blvd., Suite 250, Tampa, FL 33607 Attn. Job # (20516.437).
Internal Number: # (20516.437)
About Amgen Inc.
Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.