Career Category
Regulatory
Job Description
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.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general super

📌 Manager - International Regulatory Lead (Hyderabad)
🏢 AMGEN
📍 Hyderabad