Manager- International Regulatory Lead

Amgen

Hyderabad, India
International regulatory strategy
Product development and registration
Lifecycle management
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer

Job Summary

  • Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer.
  • 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.

Matching Summary

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer.

Skills & Requirements

Must-have

  • International regulatory strategy
  • Product development and registration
  • Lifecycle management
  • Regulatory submissions
  • Label strategy and alignment

Nice-to-have

  • Teamwork and collaboration
  • Cultural awareness and sensitivity
  • Conflict resolution skills
  • Negotiation and influencing skills

Key Requirements

  • Doctorate degree and 6 years of experience OR Master’s degree and 8 years of experience OR Bachelor’s degree and 10 years of experience
  • In-depth regulatory experience
  • Knowledge of regional countries legislation and regulations

Work Rights

Not specified

Tailored Resume

Cover Letter