**The Amgen Capability Center in Lisbon, Portugal (ACCP)** will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure and the opportunity to LIVE, WIN and THRIVE in one of Europe’s most attractive cities.
The ACCP will be temporarily located at the Maleo – Saldanha, Av. da República 18, 1050-191 Lisbon. We’re already gearing up to have our brand-new permanent office ready in the vibrant city center of Lisbon by the spring of 2022.
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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
**Regional Regulatory Affairs Associate**
Regional Regulatory Affairs provides European regional regulatory leadership/expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.
We are a team of regulatory professionals who thrive on the challenge and opportunity that leading innovative regulatory strategies provides. Together, we in the regulatory team collaborate cross-functionally to optimally develop Amgen products, leading the regulatory authority interactions to effectively drive our product strategies.
We are seeking to hire a regulatory professional who is inspired by Amgen’s science and portfolio, who can support our regulatory team and join us in our mission to serve patients.
**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 may support an European Regulatory Lead (EURL).
+ You will provide technical support for the creation, review and finalization of components of Clinical Trial Applications (CTA’s) and/or Marketing Applications as well as routine regulatory submissions in the Amgen VEEVA system
+ You will manage IMPD submission and amendments in accordance with global and European filing plans and timelines.
+ You will collaborate with Clinical Study Teams, Local Amgen Offices and CRO partners to facilitate site/study initiation.
+ You will provide EU regulatory input to the Global Regulatory Team (GRT) and advise early product teams on regulatory strategy execution with support from a supervisor.
+ You will maintain awareness of new and developing legislation, regulatory policy and technical strategy.
To do this you will:
+ Use 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.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The energetic professional we seek is a collaborative and communicative person with these qualifications:
+ Master’s degree (scientific area) OR Bachelor’s degree (scientific area) and / or up to 2 years of directly related experience.
+ Experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy (strongly preferred)
+ Knowledge and awareness of regulatory guidelines and legislation
+ Strong communication and interpersonal skills, both oral and written
+ Good planning and developing regulatory project management skills
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
+ Vast opportunities to learn, develop, and move up and across our global organization.
+ 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.
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.