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For Companies At a Glance
- Tasks: Join a dynamic team to develop regulatory strategies and support product lifecycle management.
- Company: Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Generous rewards plan, career growth opportunities, and a supportive work environment.
- Why this job: Make a real impact in healthcare while collaborating with global teams on innovative projects.
- Qualifications: Bachelor's degree and experience in manufacturing or regulatory affairs required.
- Other info: Inclusive culture that values diverse ideas and promotes personal and professional development.
The predicted salary is between 36000 - 60000 £ 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.
What you will do
Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate to join the ROOTS2 group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The RA CMC Senior Associate will interface with the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. You will be responsible for varying levels of product support, including leading projects, based upon their experience level.
Key responsibilities include:
- Contribute as a key member of the global regulatory CMC product team
- Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
- Contribute to the organization and preparation of CMC investigational product amendments, post-market supplements/variations, and new marketing applications
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
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:
- Relevant Bachelor's degree or equivalent is essential
- Experience in manufacture, process development, quality assurance, quality control, or analytical development
- Regulatory CMC specific knowledge and experience
- Developed project management and organizational skills
- Strong and effective oral and written communication skills
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.
Sr Associate Regulatory Affairs in England employer: Amgen SA
Contact Detail:
Amgen SA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr Associate Regulatory Affairs in England
✨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! Research Amgen’s products and recent news in the biotech field. This shows you're genuinely interested and ready to contribute to their mission.
✨Tip Number 3
Practice makes perfect! Get a friend to do mock interviews with you. Focus on articulating your experience in regulatory affairs clearly and confidently—this is your time to shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at Amgen.
We think you need these skills to ace Sr Associate Regulatory Affairs in England
Some tips for your application 🫡
Show Your Passion: When you're writing your application, let your enthusiasm for regulatory affairs shine through! We want to see how your passion aligns with our mission to serve patients and contribute to innovative biotechnology.
Tailor Your CV: Make sure your CV is tailored to the Senior Associate role. Highlight your relevant experience in CMC and any specific projects you've led. We love seeing how your unique background can add value to our team!
Be Clear and Concise: In your written application, clarity is key. Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point—just like we do in our work!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at Amgen.
How to prepare for a job interview at Amgen SA
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC) regulations. Familiarise yourself with the latest guidelines and how they apply to product development and registration. This will show that you're not just interested in the role but are also proactive about understanding the industry.
✨Showcase Your Project Management Skills
Be ready to discuss specific projects you've managed or contributed to in the past. Highlight your organisational skills and how you've successfully led teams or initiatives. Use examples that demonstrate your ability to meet deadlines and manage timelines effectively, as this is crucial for the role.
✨Communicate Clearly and Confidently
Since strong oral and written communication skills are essential, practice articulating your thoughts clearly. Prepare to explain complex regulatory concepts in simple terms, as you may need to interact with various stakeholders. Confidence in your communication can set you apart from other candidates.
✨Prepare Questions for Them
Interviews are a two-way street, so come prepared with insightful questions about the team, the projects you'll be working on, and Amgen's future direction in regulatory affairs. This shows your genuine interest in the company and helps you assess if it's the right fit for you.
