EU Regulatory Affairs Manager

Career Category

Regulatory

Job Description

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 pro ducts that rea ch   over   10 million patients   worldwide.   It’s   time for a career you can be proud of. Join us.

EU   REGULATORY AFFAIRS MANAGER

LIVE

What you will do

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 market ed   medicinal products.

You will support one or more products from   a n    EU   regulatory perspective.

Strategy and Execution

Depending on business needs and experience, the role may include   EU Regulatory Lead   responsibility   for 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 and   EU   regional   regulatory requirements.

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,   sc ientif ic   advice ,   Orphan Drug,   MA approval   mechanism s   and   paediatric   plans).

Support   EU   label negotiation activities.

Under general supervision   participate   in 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,   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.

Be part of our team

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.

WIN

What we expect of you

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:

Degree   educated   and   previous   experience in a similar role

Hands-on experie nce with   registration procedures in   the   region , such as   clinical trials,   pre-MAA regulatory procedures   ( eg   s cientific   a dvice , orphan   applications   or    P a ediatric   Investigation Plans   (PIPs) ) ,   MA, post - approval changes,   extensions   and renewals

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

Knowledge of   EU   legislation and regulations relating to medicinal products

Working with policies, procedures and   SOP’s   .

Strong communication   skills - both oral and written.

Ability to   anticipate   and prevent potential issues.

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

Basic   proficiency   in 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.

Gro w th o pportunities   to   learn   and 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 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.

APPLY NOW

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.

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 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 .

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