Join our team at AMGEN Capability Center Portugal, number 1 company in Best Workplaces - https://www.greatplacetowork.pt/ - ranking in Portugal (category 201-500 employees) by the Great Place to Work Institute. We have a growing team of 380 talented people and more than 38 different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. Based in Lisbon’s city center, our AMGEN office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients.

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.

• Provide technical support for the creation, review and finalization of Regulatory submissions.
• Collaborate with Regulatory Operations, Clinical Study Teams, Local Amgen Offices and CRO partners to facilitate site/study initiation.
• Maintain awareness of new and developing legislation, regulatory policy and technical strategy.
• 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.
• Establish effective relationships and communication paths across local and functional organizations.
• Enable efficiencies and seamless execution across the region countries.