At a Glance
- 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 50000 - 60000 £ 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: Job Search Place Limited
Amgen is an exceptional employer that fosters a diverse and inclusive community, empowering employees to contribute their ideas and grow within the organisation. With generous benefits that support health, finance, and work/life balance, as well as opportunities for career advancement, working in our state-of-the-art Cambridge or Uxbridge locations offers a dynamic environment where regulatory professionals can thrive and make a meaningful impact on patient outcomes.
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 serious about 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 Job Search Place Limited
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK and EU regulatory guidelines. Familiarise yourself with the specific requirements for marketing authorisations and clinical trial documentation, as this will show that you're serious about the role and understand what’s expected.
✨Showcase Your Communication Skills
Since strong communication is key in this role, prepare to discuss examples where you've effectively communicated with regulatory agencies or cross-functional teams. Think about how you can demonstrate both your oral and written skills during the interview.
✨Be Organised and Proactive
Prepare a few examples of how you've managed regulatory projects in the past. Highlight your organisational skills and any experience with tools like Veeva Vault. This will help illustrate your ability to handle multiple submissions and deadlines efficiently.
✨Engage with the Company Culture
Research Amgen's values and culture before the interview. Be ready to discuss how you can contribute to their diverse and inclusive community. Showing that you align with their mission will make a positive impression.
