Career Category
Regulatory
Job Description
Manager - International Regulatory Lead
Role Name: Manager – International Regulatory Lead (IRL)
Department Name: International Regulatory Team, Global Regulatory Affairs
Role GCF: 5A
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver cutting-edge medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE ROLE
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency ou