EU Regulatory Affairs Manager

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Join us.

In this vital role you will work to ensure that Amgenacquiresandmaintainsall the requiredEUlicensesin order tosupport clinical trials for investigational medicinal products as well as marketed medicinal products.

You will support one or more products fromanEUregulatory perspective.

• Depending on business needs and experience, the role may includeEU Regulatory Leadresponsibilityfor one or more products.

• Plan and manage regulatory submissions (e.g.clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans andEUregionalregulatory requirements.

• Under general supervision, implement product related regulatory strategies, Regulatory Affairsprocessesand activity planning in accordance withEU regional legislation and regulatory requirements. Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.

• Provide regulatory guidance on regional regulatory mechanisms tooptimizeproduct development (e.g.expediting FIH studies,scientific advice,Orphan Drug,MA approvalmechanismsandpaediatricplans).

• SupportEUlabel negotiation activities.

• Under general supervisionparticipatein the development and execution of regional regulatory product strategies.

• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.

• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.

• Perform regulatory research to obtain relevant histories,precedence and other information relevant to regional product advancement.

• Under supervision evaluate and communicate impact of relevant regional regulations,guidances, current regulatory environment and competitor labelling.

We are currently looking for x3

EU Regulatory Affairs Managers between Portugal and the United Kingdom, joining theEUOncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe.

You will be working with colleagues whoare responsible for leading the European regulatory strategies and submissions for development and marketed products from first-in human clinical trials to marketing authorisation, and throughout the products lifecycle.

We are all different, yet we all use our unique contributions to serve patients.

What weseekin you as anexperiencedprofessional, are these qualifications and skills:

• Degreeeducatedandpreviousexperience in a similar role

• Hands-on experience with registration procedures intheregion, such as clinical trials,pre-MAA regulatory procedures(egscientificadvice, orphan applicationsor
  
  Paediatric
  
  Investigation Plans(PIPs)),MA, post-approval changes,extension sand renewals

• Experience developing regulatory strategies for products in clinical development and post-marketing phases.

• Knowledge ofEUlegislation and regulations relating to medicinal products

• Working with policies, procedures andSOP’s.

• Strong communication skills - both oral and written.

• Ability toanticipateand prevent potential issues.

• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

• Basicproficiencyin using AI tools to support day-to-day work.