At a Glance
- Tasks: Lead regulatory strategy and submissions for innovative medicinal products across Europe.
- Company: Join Amgen, a pioneering biotechnology company dedicated to improving health outcomes.
- Benefits: Flexible work options, generous rewards, and opportunities for personal and professional growth.
- Other info: Be part of a diverse team driving successful drug development in a dynamic environment.
- Why this job: Make a real impact in drug development while shaping the future of healthcare.
- Qualifications: Degree in a scientific discipline and extensive regulatory experience required.
The predicted salary is between 51750 - 63250 £ per year.
EUROPEAN REGULATORY AFFAIRS LEAD LIVE
What you will do In this vital role, you will ensure Amgen obtains and maintains the regulatory licenses required to support clinical development and commercialization of medicinal products.
You will represent the region in shaping regulatory strategy, providing regional expertise, and collaborating with stakeholders to ensure regional requirements are effectively incorporated into global plans.
- 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 local regulatory requirements
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
- Lead development of regional regulatory documents and meetings in accordance with GRT strategy
- Provide regulatory direction on regional regulatory mechanisms to optimize product development (e. g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
- Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
- Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
- Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Be part of our team You would be joining the European General Medicine Regulatory team, part of the Global Regulatory Affairs function in Europe.
You would 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.
This team is leading the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflamation, Endocrine and Bone disease areas, as well as pre-approval filing activities for Biosimilars.
- WIN What we expect of you
- Degree educated in a scientific discipline
- Extensive experience in regional regulatory environment
- Proven track record of developing and executing regional 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 region for MA, post approval changes, extensions and renewals.
- 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
- 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: 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 68,000.00 to 92,000.00.
Actual pay will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
- Application due date: 19th of August 2026
- Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, 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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
- For more information, visit www. amgen. com and follow us on www. twitter. com/amgen
- #J-18808-Ljbffr
European Regulatory Affairs Lead in Uxbridge employer: Amgen Inc. (IR)
Amgen is an exceptional employer that prioritises a fair and inclusive workplace culture, offering robust support for employee relations across the EMEA region. With a strong commitment to professional development, employees have access to continuous growth opportunities while collaborating with dedicated teams in a dynamic environment. Located in a vibrant area, Amgen provides unique advantages such as a focus on compliance and ethical practices, ensuring that every team member can thrive and contribute meaningfully to the organisation's success.
StudySmarter Expert Advice🤫
We think this is how you could land European Regulatory Affairs Lead in Uxbridge
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
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If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Amgen Inc. (IR). You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Amgen Inc. (IR)!
We think you need these skills to ace European Regulatory Affairs Lead in Uxbridge
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Amgen Inc. (IR) that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Amgen Inc. (IR).
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Amgen Inc. (IR) does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Amgen Inc. (IR)
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Amgen Inc. (IR). You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Amgen Inc. (IR)'s culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Amgen Inc. (IR). This shows your passion for the industry!
