Global Regulatory Affairs Director - Inflammation and Rare Disease

About the role

Amgen is seeking a Regulatory Affairs Director to support products in the Inflammation and Rare Disease therapeutic area. The role leads the Global Regulatory Team (GRT) and develops a global regulatory strategy covering worldwide requirements, product development, global registration, regional labeling and regulatory agency interactions. It is a product-facing position.

Key responsibilities

• Develop and execute the global regulatory product strategy and lead the GRT
• Represent Regulatory on the product team and other commercialization governance bodies
• Develop the Global Regulatory Strategic Plan and give regulatory input into the product's Global Strategic Plan
• Identify and communicate regulatory risks and represent GRA on the product team
• Develop registration strategies and plans to achieve regulatory approval and product labeling
• Guide the development of the core data sheet and lead global regulatory filings (clinical trial applications, marketing applications, label extensions, CMC changes)
• Ensure consistent, evidence-based global product communication and monitor the impact of global regulations and guidance
• Assess regulatory mechanisms such as expediting FIH studies, Orphan Drug, Fast Track, conditional or accelerated approval, compassionate use and pediatric plans
• Lead regulatory agency communications, attend key regulatory agency meetings and represent Amgen on external partnership teams

Required profile

• Basic qualification: doctorate with 4 years of regulatory experience in biotech or science, or master's degree with 7 years, or bachelor's degree with 9 years of regulatory experience in biotech or science
• Preferred: ability to lead and build teams, strong oral and written communication, understanding of scientific and clinical information, anticipation of strategic issues, conflict resolution, cultural awareness, planning and prioritizing, negotiation skills

What we offer

• Annual salary range of $189,632.45 to $256,561.55 in the U.S. (excluding Puerto Rico), varying with skills, experience and qualifications
• Health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and flexible spending accounts
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, time-off plans and flexible work models where possible