EU Regulatory Affairs Manager

Amgen seeks an experienced regulatory affairs manager to oversee EU licensing and regulatory submissions for clinical trial and marketed medicinal products. The role involves managing product strategies, regulatory filings, and compliance across EU regions while supporting one or more products throughout their lifecycle.

Responsibilities

• Plan and manage regulatory submissions including clinical trial and marketing applications in compliance with EU requirements
• Implement product regulatory strategies and activity planning according to EU legislation and global filing plans
• Provide regulatory guidance on mechanisms to optimize product development and support label negotiations
• Maintain awareness of developing legislation, regulatory policy, and technical guidance relevant to products
• Evaluate and communicate impact of regional regulations and competitive labelling on product advancement

Requirements

• Degree-educated with previous regulatory affairs experience in similar role
• Hands-on experience with EU registration procedures including clinical trials, MAA, and post-approval changes
• Experience developing regulatory strategies for products in clinical and post-marketing phases
• Knowledge of EU legislation and regulations for medicinal products
• Strong oral and written communication skills
• Ability to anticipate issues and resolve conflicts constructively
• Basic proficiency with AI tools for daily work support