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- Tasks: Lead regulatory submissions and ensure compliance for medicines in the UK and Ireland.
- Company: Join Amgen, a global leader in biotechnology with a passionate team.
- Benefits: Flexible work options, generous rewards, and opportunities for career growth.
- Other info: Be part of a diverse community that values your ideas and contributions.
- Why this job: Make a real impact on patient outcomes while developing your regulatory expertise.
- Qualifications: Degree educated with experience in regulatory affairs and strong communication skills.
The predicted salary is between 45000 - 55000 £ per year.
Reporting to the Director Regulatory Affairs UK & Ireland Affiliate, you will join a team of 10 regulatory professionals passionate about delivering the best outcomes for our medicines to patients.
What you will do
- Support and, where appropriate, lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements.
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements and support licence and clinical trials activities.
- Contribute to and execute local filing plans.
- Act as a key contact for agency interactions for an assigned portfolio of products.
- Collate, distribute, exchange and archive regulatory information with colleagues across the business.
- Participate in regulatory and affiliate process improvements initiatives.
- Review promotion and non-promotion materials to ensure compliance with local licence, company procedures and Code of Practice.
What we expect of you
- Degree educated.
- Experience in the management of marketing authorisations in the UK and the EU.
- Experience in/knowledge of developing and maintaining clinical trial documentation in UK and the EU (e.g. IMPDs, IMPD amendments) and ability to work with increasing autonomy.
- Knowledge and awareness of the relevant regulatory guidelines and legislation.
- Strong communication skills both oral and written.
- Organisational skills & developing or demonstrated regulatory project management skills.
- Experience with Veeva Vault.
What you can expect of us
- 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.
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.
Senior Associate Regulatory Affairs in Cambridge employer: Amgen SA
Contact Detail:
Amgen SA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Associate Regulatory Affairs in Cambridge
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Amgen on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on regulatory guidelines and be ready to discuss how your experience aligns with the role. We want to see your passion for regulatory affairs shine through!
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed projects or submissions in the past. We love hearing about your ability to keep things on track and meet deadlines.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Amgen.
We think you need these skills to ace Senior Associate Regulatory Affairs in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Senior Associate Regulatory Affairs role. Highlight your experience with regulatory submissions and project management, as these are key for us.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background aligns with our mission at Amgen. Keep it concise but impactful!
Showcase Your Communication Skills: Since strong communication is crucial for this role, make sure your written application is clear and professional. Avoid jargon and keep your language straightforward so we can easily see your qualifications.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Amgen SA
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory guidelines and legislation relevant to the UK and EU. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed marketing authorisations or clinical trial documentation in the past. Highlight your organisational skills and any experience with tools like Veeva Vault, as this will demonstrate your ability to handle the responsibilities of the role effectively.
✨Communicate Clearly
Strong communication skills are key in this role. Practice articulating your thoughts clearly and concisely, both verbally and in writing. You might even want to prepare a few points about how you’ve effectively communicated with regulatory agencies in previous roles.
✨Be Ready for Team Dynamics
Since you'll be part of a team of regulatory professionals, think about how you can contribute to a collaborative environment. Be prepared to discuss how you’ve worked with colleagues across different departments to achieve regulatory goals, as teamwork is crucial in this field.