Manager- International Regulatory Lead

Responsibilities

• Provide regulatory leadership and expertise for international countries to optimize product development and regulatory approvals.
• Develop international regulatory strategies and contribute to global regulatory plans.
• Support regulatory product compliance, including RIM, PMCs, and agency commitments.
• Advise on local label strategy and ensure alignment with reference labels.
• Build effective communication paths across global, regional, and local functional organizations.
• Plan regulatory submissions for clinical trials, marketing authorization applications, and lifecycle management.
• Lead internal discussions regarding agency meetings and communicate outcomes to relevant teams.
• Support local regulatory teams in triaging queries from health authorities.
• Maintain awareness of new legislation, regulatory policy, and technical guidance.

Requirements

• Doctorate degree with 6 years of directly related experience, OR
• Master’s degree with 8 years of directly related experience, OR
• Bachelor’s degree with 10 years of directly related experience.
• Strong knowledge of regulatory principles and drug development processes.
• Understanding of national legislation and regulations relating to medicinal products.
• Proven ability to work with policies, procedures, and SOPs.
• Excellent communication, negotiation, and influencing skills.
• Ability to resolve conflicts and communicate complex scientific/clinical information.

Preferred Qualifications

• 8-13 years of experience with a degree and in-depth regulatory expertise.
• In-depth knowledge of regional country legislation and regulations relating to medicinal products.

About the Company

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. A biotechnology pioneer since 1980, Amgen discovers, develops, manufactures, and delivers innovative medicines to help millions of patients worldwide.