Senior Regulatory Affairs Manager

Career Category

Regulatory

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.  As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

UK AND IRELAND REGULATORY AFFAIRS SENIOR MANAGER

What you will do

Let’s do this. Let’s change the world. In this vital role, you will lead regulatory activities across the UK and Ireland, ensuring Amgen obtains and maintains the necessary approvals to support clinical development and commercialization of medicinal products. You will shape UK regulatory strategies, influence global plans, and oversee local post-approval activities in Ireland, ensuring alignment with regulatory requirements and business objectives.

- Lead the development and execution of UK regulatory strategies, including risk assessment, contingency planning, and regulatory pathways.

- Plan and manage regulatory submissions, including clinical trial and marketing applications, in compliance with local requirements and global strategies.

- Provide strategic regulatory guidance to optimize product development and lifecycle management.

- Oversee post-approval regulatory activities in Ireland for Centrally Authorised products, ensuring local compliance.

- Lead the preparation of regulatory documentation and interactions with Health Authorities, ensuring effective communication and follow-up.

- Collaborate with global and cross-functional stakeholders to integrate UK and Ireland regulatory requirements into product strategies.

Be part of our team

You would be joining the UK and Ireland Regulatory team. You would be working with colleagues who are responsible for leading the UK regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.

This team is leading the regulatory activities for development assets, established products and Biosimilars.

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 in a scientific discipline

- Extensive experience in UK regulatory environment

- Proven track record of developing and executing UK regulatory strategy

- In-depth understanding of the drug life cycle and development process from a regulatory perspective

- In-depth understanding of the registration procedures in the UK for MA, post approval changes, extensions and renewals including the various regulatory routes.

- Ability to lead teams and work collaboratively in a dynamic environment

- Proactive approach to problem solving

- Ability to understand and communicate scientific/clinical information

- Ability to anticipate regulatory agency expectations

- Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.