HOW MIGHT YOU DEFY IMAGINATION?
If you feel likeyou’repart of something bigger,it’sbecause you are. AtAmgenour 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,manufacturingand delivering ever-better products that reachover10 million patientsworldwide.It’stime for a career you can be proud of. Join us.
EUREGULATORY AFFAIRS MANAGER
In this vital role you will work to ensure that Amgenacquiresandmaintainsall the requiredEUlicensesin order tosupport clinical trials for investigational medicinal products as well as marketedmedicinal products.
You will support one or more products froman EUregulatory perspective.
Under general supervision, implement product related regulatory strategies, Regulatory Affairsprocessesand activity planningin accordance withEU regionallegislation and regulatoryrequirements. Providecontent guidance for regional regulatory documents and meetingsin accordance withglobal strategy.
Provideregulatory guidance on regional regulatory mechanisms tooptimizeproduct development (e.g.expediting FIH studies,scientificadvice,Orphan Drug,MA approvalmechanismsandpaediatricplans).
We are currently looking for x3EURegulatory 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 forleading the European regulatory strategies and submissions for development and marketed products from first-in human clinical trials to marketingauthorisation, and throughout the products lifecycle.
We are all different, yet we all use our unique contributions to serve patients.What weseekin you as anexperienced professional, are these qualifications and skills:
Hands-on experience withregistration procedures intheregion, such asclinical trials,pre-MAA regulatory procedures(egscientificadvice, orphanapplicationsor PaediatricInvestigation Plans(PIPs)),MA, post-approval changes,extensionsand renewals
Generous Total Rewards Plancomprisinghealth, finance and wealth, work/life balance, and career benefits
LOCATION:Flexibility to work from home with few days per month working from our Cambridge,Uxbridgeor Lisbonoffice.
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 patientsabove 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 provideda reasonableaccommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.
