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Regulatory Affairs Manager

4 months ago

Cambridge Cambridgeshire, United Kingdom Amgen SA Full time

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.

REGULATORY AFFAIRS MANAGER

LIVE

What you will do

In this vital role you will support one or more oncology products from a European regional regulatory perspective and take ownership of leading the regulatory strategies related to those products.

  • Plan and manage regulatory submissions (e.g. clinical trial applications, variations and supporting marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
  • Develop and/or implement innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements.
  • Lead and/or participate in development of regional regulatory documents and meetings in accordance with the regulatory strategy
  • Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans)
  • You will direct and/or participate in the development of the regional product label by collaborating with internal stakeholders to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
  • You will identify and mitigate regulatory risks and support contingency planning

Be part of our team

You would be joining the European Oncology Regulatory team, part of the Global Regulatory Affairs function in Europe. Our Regulatory Affairs professionals team are embedded in the drug development process; and play a critical role in successful product development.

You will be working with cross-functional teams, including those in Development, Medical, Commercial, and Value and Access; and will be part of global and regional regulatory teams. Your interactions with these colleagues and input into these teams will be key to ensure the successful development of and patient access to Amgen’s innovative Oncology products.

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 in a scientific discipline
  • Relevant experience in Regulatory Affairs
  • In-depth understanding of the drug development process from a Regulatory perspective
  • In-depth understanding of the European registration procedures for MA, post approval changes, extensions and renewals
  • Strong knowledge of and experience in the European regulatory environment.
  • Knowledge of the oncology therapy area is desirable but not essential.
  • Ability to understand and communicate scientific/clinical information
  • Anticipate regulatory agency responses to strategy
  • Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
  • Experience with national legislation and regulations relating to medicinal products

THRIVE

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 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 Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

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’s Innovation

At Amgen, innovation is more than just a buzzword. It’s how we give new options and hope to patients with serious illnesses – from widespread cancers to orphan diseases like acute lymphoblastic leukemia (ALL). Our heritage and our future are the pursuit of novel therapies that patients, physicians and caregivers value most.

Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTEs), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules – across many targets and more than a dozen tumor types. We are looking for top talent to join our Regulatory team to ensure these molecules become medicines and realize their potential for helping patients.

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