EU Regulatory Affairs Manager

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

LIVE

What you will do

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.

Strategy and Execution

• 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 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).

• 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.

Regulatory Research

• 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,precedenceand other information relevant to regional product advancement.

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

Be part of our team

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.

WIN

What we expect of you

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:

• Degreeeducatedandpreviousexperience in a similar role

• Hands-on experience withregistration procedures intheregion, such asclinical trials,pre-MAA regulatory procedures(egscientificadvice, orphanapplicationsor PaediatricInvestigation Plans(PIPs)),MA, post-approval changes,extensionsand 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 communicationskills - 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.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being.

• Growth opportunitiestolearnand move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• 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.

APPLY NOW

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.

careers.amgen.com

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.