International Regulatory Lead Manager

About the role

Amgen's International Regulatory Team, Global Regulatory Affairs is looking for a Manager - International Regulatory Lead (IRL). The IRL provides regulatory leadership and expertise for international countries for one or more Amgen products, working with various functions and local regulatory teams to optimize product development and regulatory approvals, and to develop international regulatory strategy and support in-country product registrations and life cycle management.

Key responsibilities

• Advise Global teams on regulatory implications of global clinical development, marketing applications and their objectives
• Provide regulatory direction on international mechanisms such as expediting first-in-human studies, orphan drug and expedited designations, regulatory reliance mechanisms, compassionate use and pediatric plans
• Plan regulatory submissions (clinical trials, marketing authorization applications, lifecycle management) under general supervision
• Contribute to international regulatory strategy documents, including filing plans, risk assessment and contingency planning
• Maintain clinical trial and marketing application documentation (excluding CMC) and author or redact documents for filings
• Lead the international label submission strategy, negotiate with cross-functional teams and own label deviation requests
• Support local teams in triaging health authority queries and leverage knowledge management
• Take part in the Global Regulatory Team and global clinical and labelling teams, sharing regulatory information and advice on international considerations
• Agree product strategy with peers, including projected submission and approval timelines, and keep local teams aligned
• Stay aware of new legislation, regulatory policy and technical guidance, and perform regulatory research

Required profile

• Doctorate, or Master's degree with 3 years of relevant regional regulatory experience, or Bachelor's with 5 years, or Associate degree with 10 years, or high school diploma/GED with 12 years of relevant regional regulatory experience
• Knowledge of the international regulatory environment for clinical trial applications, non-clinical and clinical variations to marketing authorizations and product labelling for biotechnology and/or oncology products
• Understanding of regulatory principles and of registration procedures and challenges in international countries

Required skills

• Good-to-have: conflict resolution and cultural awareness
• Strong oral and written communication, ability to explain scientific and clinical information
• Ability to work with global, local and virtual teams, with initiative, planning and negotiation skills