Regulatory Affairs Mgr

Location: Thousand Oaks, CA
Date Posted: 06-16-2017
Day to Day Responsibilities:     
Perform regulatory research to obtain relevant histories, precedence and other information relevant to product advancement in the US; Under supervision evaluate and communicate impact of relevant US regulations, guidance’s, current regulatory environment and competitor labeling; lead Health Authority Interactions; With general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment; Document and communicate details and outcomes of FDA interactions to GRT and relevant sr. management; Under general supervision, participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategy - includes contingency regulatory planning/risk assessment

This is an opportunity for a Manager position in Amgen's Global Regulatory Affairs and Safety group. The purpose of this role is to achieve the desired labeling by developing and executing US regulatory strategies. Execution of the US regulatory strategy includes: Planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirements; ensuring that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational and marketed products in the US; ensuring regulatory compliance; managing effective US regulatory agency interactions; providing content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions); under general supervision, developing US regulatory strategies, regulatory risks and predictions of interactions with regulatory agencies•; providing regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)

"This posting is for Contingent Worker, not an FTE"
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