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Manager- International Regulatory Lead

India, Hyderabad Employment contract · Job Posted May 28, 2026
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Job 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.

Job Responsibility

  • Provide regulatory leadership & expertise for International countries for one or more Amgen products
  • Collaborate 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
  • 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

Requirements

  • Doctorate degree and 6 years of directly related experience
  • OR Master's degree and 8 years of directly related experience
  • OR Bachelor's degree and 10 years of directly related experience

Nice to have

  • 8-13 years of experience with degree and in-depth regulatory experience and/or related to the region
  • In-depth knowledge of regional countries legislation and regulations relating to medicinal products

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