EU Regulatory Affairs Manager

About the role

AMGEN is hiring three EU Regulatory Affairs Managers for its EU Oncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe. The role ensures that AMGEN acquires and maintains the required EU licenses to support clinical trials for investigational medicinal products and marketed medicines, and supports one or more products from an EU regulatory perspective. The position is based in Lisbon.

Key responsibilities

• Depending on business needs and experience, the role may include EU Regulatory Lead responsibility for one or more products.
• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) in line with global filing plans and EU regional requirements.
• Implement product-related regulatory strategies, processes and activity planning under general supervision, and provide content guidance for regional regulatory documents and meetings.
• Provide regulatory guidance on mechanisms such as expediting first-in-human studies, scientific advice, Orphan Drug and MA approval pathways, and paediatric plans.
• Support EU label negotiation activities and take part in regional regulatory product strategies.
• Predict expectations and risks associated with regulatory agency outcomes.
• Maintain awareness of new legislation, policy and technical guidance, and carry out regulatory research on precedents and competitor labelling.

Required profile

• Degree-educated with previous experience in a similar role.
• Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA procedures (scientific advice, orphan applications, Paediatric Investigation Plans), marketing authorisation, post-approval changes, extensions and renewals.
• Experience developing regulatory strategies for products in clinical development and post-marketing phases.
• Knowledge of EU legislation and regulations relating to medicinal products.

Required skills

• Working with policies, procedures and SOPs.
• Strong oral and written communication skills.
• Ability to anticipate and prevent issues, resolve conflicts and propose constructive courses of action.
• Basic proficiency in using AI tools to support day-to-day work.

What we offer

• Vast opportunities to learn, develop and move up and across the global organisation.
• A generous total rewards plan covering healthcare, finance, wealth and career benefits.
• Flexible work arrangements.