EU Regulatory Affairs Manager

Overview

As Regulatory Affairs Manager at Amgen, you will ensure licensing for clinical trials and marketed products, supporting regional product lines. You will plan submissions, implement regulatory strategies, and guide regional regulatory documents in line with global plans. You will assess regulatory risks, perform regulatory research, and advise on regional mechanisms and label negotiations. You will collaborate with the European Oncology Regulatory team to drive development and lifecycle regulatory activities, contributing to patient-focused therapies at scale.

Pay / Benefits

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Responsibilities

• Plan and manage regulatory submissions (clinical trial and marketing applications) in compliance with global and local requirements
• Support one or more products from a regional regulatory perspective
• Implement product-related regulatory strategies and processes per national regulations
• Provide content guidance for regional regulatory documents and meetings
• Advise on regional regulatory mechanisms to optimize development (FIH, Orphan Drug, Fast Track, compassionate use, paediatric plans)
• Support regional label negotiation activities
• Contribute to the development and execution of regional regulatory product strategies
• Develop predictions for expectations and risks with respect to regulatory agencies
• Maintain awareness of new legislation, policy, and regulatory guidance
• Perform regulatory research to build case histories relevant to regional advancement
• Evaluate impact of regional regulations and guidance on product labeling and environment

Key requirements

• Scientific Degree
• Knowledge of regulatory principles
• Experience with policies, procedures and SOPs
• Understanding of legislation and regulations relating to medicinal products
• Awareness of regional registration procedures for clinical trials, MA, post-approval changes, renewals
• Knowledge of drug development
• Experience in regional regulatory environment
• Strong oral and written communication skills
• Ability to communicate scientific/clinical information
• Ability to anticipate potential issues
• Ability to resolve conflicts and propose constructive actions

• Strong communication skills
• Ability to anticipate and prevent issues
• Conflict resolution
• Regulatory principles and processes
• Regulatory requirements for medicinal products
• Regional regulatory environment knowledge

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