At a Glance
- Tasks: Ensure EU licenses for clinical trials and marketed products, managing regulatory submissions.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Flexible work options, generous rewards, and opportunities for personal and professional growth.
- Other info: Be part of a diverse team that values your unique contributions and ideas.
- Why this job: Make a real impact in healthcare by shaping regulatory strategies for innovative treatments.
- Qualifications: Degree educated with experience in regulatory affairs and strong communication skills.
The predicted salary is between 63000 - 77000 £ per year.
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.
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 marketed medicinal products. You will support one or more products from an EU regulatory perspective.
- 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.
- 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, scientific advice, Orphan Drug, MA approval mechanisms and paediatric plans).
- Support EU label negotiation activities.
- Participate in the development and execution of regional regulatory product strategies.
- 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.
- Evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.
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.
What we expect of you
- Degree educated and previous experience in a similar role.
- Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA regulatory procedures (e.g. scientific advice, orphan applications or Paediatric 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.
- 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.
What you can expect of us
- Growth 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 or Uxbridge offices.
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.
EU Regulatory Affairs Manager in Edinburgh employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. As an EU Regulatory Affairs Manager, you will be part of a diverse and inclusive team dedicated to serving patients, with ample opportunities for professional development and a generous Total Rewards Plan. With flexible working arrangements from our offices in Cambridge, Uxbridge, or Lisbon, you can enjoy a fulfilling career while maintaining a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land EU Regulatory Affairs Manager in Edinburgh
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We think you need these skills to ace EU Regulatory Affairs Manager in Edinburgh
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Amgen!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Amgen that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Amgen!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Amgen, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Amgen
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Amgen that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Amgen’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
