Senior Manager, International Regulatory Affairs

About the role

Amgen's International Regulatory Affairs team provides regulatory leadership for the development, registration and lifecycle management of its molecules. This Senior Manager (Sr. Manager) leads one or more products with complex programmes and high impact, acting as the International Regulatory Lead. The role covers regulatory compliance, product labelling and regulatory strategy.

Key responsibilities

• Develop the international regulatory strategy and contribute to global regulatory plans, and support regulatory product compliance (RIM, PMCs, ESC levels, agency commitments).
• Advise global teams on regulatory implications of clinical development and marketing application plans, and guide mechanisms such as expediting first-in-human studies, orphan drug designation, compassionate use and paediatric plans.
• Plan regulatory submissions (clinical trials, marketing authorisation applications, lifecycle management) and contribute to regulatory filing plans and risk assessments.
• Maintain CTA/MA documentation, author or redact documents for filings, and lead internal discussions on agency meetings.
• Lead the international product label strategy with the Labeling Working Group, manage label submissions and negotiate with cross-functional teams.
• Support local regulatory teams in triaging health authority queries, advise on promotional and non-promotional materials, and support process improvement.
• Take part in the Global Regulatory Team, Evidence Generation Team, Labeling Working Group and Clinical Study Team, share regulatory information and mentor junior International Regulatory Leads.

Required profile

• Master's degree in a scientific area and 6 years of directly related experience, or Bachelor's degree in a scientific area and 8 years of directly related experience.
• Preferred: degree and in-depth regulatory experience, and in-depth knowledge of regional countries' legislation and regulations on medicinal products.

Required skills

• Knowledge of regulatory principles, policies, procedures and SOPs, and of drug development.
• General knowledge of national legislation on medicinal products and awareness of registration procedures for CTAs, MAs and lifecycle management.
• Strong teamwork, oral and written communication, negotiation and influencing skills, and cultural awareness across regions and countries.