HOW MIGHT YOU DEFY IMAGINATION?
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.
EU REGULATORY AFFAIRS MANAGER
In this vital role you will work to ensure that Amgen acquires and maintains all the required EU licenses in order to support clinical trials for investigational medicinal products as well as marketed medicinal products.
You will support one or more products from an EU regulatory perspective.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with EU 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 to optimize product development (e.g. expediting FIH studies, scientific advice, Orphan Drug, MA approval mechanisms and paediatric plans).
We are currently looking for x3 EU Regulatory Affairs Managers between Portugal and the United Kingdom, joining the EU Oncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe.
You will be working with colleagues who are 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 we seek in you as an experienced professional, are these qualifications and skills:
Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA regulatory procedures (eg scientific advice, orphan applications or Paediatric Investigation Plans (PIPs)), MA, post-approval changes, extensions and renewals
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
LOCATION: Flexibility to work from home with few days per month working from our Cambridge, Uxbridge or Lisbon office.
The expected gross pay range for this role in Portugal is EUR 48,957.00 to 66,237.00. Actual pay will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
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.
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.
