Amgen Inc.; Senior Associate Regulatory Affairs; Cambridge, MA: Facilitate product development by supporting global registration and life-cycle management for global products, such as NDA, BLA, IND, CTA and post-marketing supplements. Assessing non-conformances and recommending change controls; Using various electronic document management systems (EDMS) tools; Authorizing annual report summaries for Annual Reports submissions; Assisting with the preparation for the FDA biannual inspections; Evaluating and reporting manufacturing changes that impact the submission; Developing regulatory strategies and managing submission planning; and Handling queries from various regulatory authorities. Interested candidates send resume to: J. Cummings, 2202 N. Westshore Blvd., Suite 250, Tampa, FL 33607 Attn. Job # (20516.610).
Internal Number: # (20516.610)
About Amgen Inc.
Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.