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Regulatory Affairs Senior Manager - NB50992814Amgen - Thousand Oaks, CAJob Summary: This role will lead the development of regulatory strategy for International Expansion (IE) commercialization and life cycle management of assigned products and oversee its execution. Responsibilities: - Develop the product strategy across IE - Manage the execution of the strategy for Market Applications and post-market supplements/variations across IE - Participate in the development of product label by collaborating with the Labeling Working Group to define commercial objectives in the context of regulatory guidance and precedent in IE region - Member of Global Regulatory Team (GRT), collaborates with the Global Regulatory Leader (GRL) to develop executable Product Team goals - Provide guidance on regional regulatory mechanisms to optimize product registration - Interface... See job listing >30+ days ago from BioSpace - Save - Block - Flag - More Tools...
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Amgen
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Headquarters:
1 Amgen Center Dr
Thousand Oaks, CA 91320
Phone: 805-447-1000
http://www.amgen.com - Line of Business: Mfg Biological Products
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Key Numbers:
Company Type Public (AMGN:NMS) Company Revenue $500M+ Company Size More than 5000 employees
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