Career Category
Regulatory
Job Description
Sr Manager - Gen Med / Biosims International Regulatory Lead

The Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements.

Group Purpose
International Regulatory Affairs provides regulatory leadership/ expertise for the development, registration, and lifecycle management of all Amgen molecules.

Job Summary
The International Regulatory Lead (Sr. Manager) is assigned to lead one or more Amgen products. The product(s) assigned have complex programs/strategies and high 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.
- Provide SME support to process improvement projects, as assigned.

KEY ACTIVITIES
Strategy & 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).
- With minimal supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- With minimal supervision,

📌 Sr Mgr Regulatory Affairs (Hyderabad)
🏢 AMGEN
📍 Hyderabad