Career Category
Regulatory
Job Description
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 creative 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
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.

Job Summary
The International Regulatory Lead (Manager) is assigned to lead one or more Amgen products. The product(s)



assigned have medium complexity programs/strategies and medium impact to Amgen.
- Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.
- Develop the international regulatory strategy and contribute to Global regulatory plans.
- Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).
- Support and advise on the local label strategy and alignment to cCDS/reference label.
- Build effective relationships and communication paths across global, regional, local and functional organizations.
- Enable efficiencies and seamless execution across the international countries.
- Contribute to process improvement projects, as assigned.

Key Activities

STRATEGY AND EXECUTION
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives.
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📌 Manager- International Regulatory Lead (Hyderabad)
🏢 AMGEN
📍 Hyderabad