Associate Regulatory Affairs

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.

LIVE

WHAT YOU WILL DO

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.

WIN

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced and autonomous professional, with these qualifications and skills:

• Master’s degree or Bachelor’s degree (scientific area) and 2 years of directly related experience.
• Strong communication and interpersonal skills, both oral and written.
• Good planning and developing regulatory project management skills.
• Experience or knowledge with European Medicines Agency Portals and systems, Veeva systems; preference and general skills to work in systems and learn and adapt to new systems.
• Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) is a plus.

THRIVE

WHAT YOU CAN EXPECT OF US

• Vast opportunities to learn, develop, and move up and across our global organization.
• A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
• Flexible work arrangements.

Apply now

Objects in your future are closer than they appear. Join us.

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EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.