ASSOCIATE REGULATORY AFFAIRS

Amgen’s Regional Regulatory Affairs team offers European regulatory leadership and execution across the development, registration, and lifecycle management of all Amgen molecules. The team thrives on innovation and collaborates cross-functionally to advance product strategies through regulatory authority interactions. Our team is seeking a motivated regulatory professional, inspired by Amgen’s science, to support our mission of serving patients.

Let’s do this. Let’s change the world. In this vital role you will be assigned to one or more Amgen products and support a Regional Regulatory Lead (RRL) or lead a program under the supervision of an expert regulatory lead.

• Execute the regional regulatory strategy and regional regulatory plans.
• Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities.
• Use of Amgen systems and document management.
• Ensure and support regulatory product compliance.
• Work with Policies and SOPs.
• Build effective relationships and communication paths across local and functional organizations.
• Enable efficiencies and seamless execution across the region countries.