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For Companies At a Glance
- Tasks: Join a dynamic team to support regulatory strategies and product development.
- Company: Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Generous rewards, health benefits, and opportunities for personal and professional growth.
- Why this job: Make a real impact in biotechnology while collaborating with global teams.
- Qualifications: Bachelor’s degree and experience in manufacturing or regulatory affairs required.
- Other info: Inclusive culture that values diverse ideas and offers career advancement.
The predicted salary is between 36000 - 60000 ÂŁ per year.
HOW MIGHT YOU DEFY IMAGINATION? 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
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 - CMC (x2) in Cambridge employer: Amgen
Contact Detail:
Amgen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr Associate Regulatory Affairs - CMC (x2) in Cambridge
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, or even reach out to current Amgen employees on LinkedIn. Building relationships can open doors that a CV just can't.
✨Ace the Informational Interview
If you can, set up an informational interview with someone in regulatory affairs. It’s a great way to learn more about the role and show your genuine interest. Plus, it gives you a chance to ask questions and make a lasting impression!
✨Showcase Your Skills
When you get the chance to chat with recruiters or during interviews, highlight your project management and communication skills. Use specific examples from your experience to demonstrate how you can contribute to the RA CMC team at Amgen.
✨Apply Through Our Website
Don’t forget to apply directly through the Amgen website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the team!
We think you need these skills to ace Sr Associate Regulatory Affairs - CMC (x2) in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Senior Associate Regulatory Affairs role. Highlight your relevant experience in regulatory CMC, project management, and any specific achievements that showcase your ability to contribute to our mission.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you’re passionate about regulatory affairs and how your background makes you a perfect fit for the ROOTS2 team. Don’t forget to mention your enthusiasm for serving patients!
Showcase Your Communication Skills: Since strong written communication is key for this role, ensure your application materials are clear, concise, and free of errors. This is your opportunity to demonstrate your ability to communicate effectively, just like you would in the role.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Amgen
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in Chemistry, Manufacturing, and Controls (CMC). Familiarise yourself with the latest guidelines and regulations that impact product development and registration. This will show that you're not just interested in the role but are also well-prepared to contribute from day one.
✨Showcase Your Project Management Skills
Since the role involves leading projects, be ready to discuss your project management experience. Prepare specific examples where you've successfully managed timelines, coordinated with cross-functional teams, or navigated challenges. This will demonstrate your organisational skills and ability to drive results.
✨Communicate Clearly and Confidently
Strong communication is key in this role, so practice articulating your thoughts clearly. Whether it's discussing regulatory documents or training staff, being able to convey complex information simply will set you apart. Consider doing mock interviews to refine your delivery.
✨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 approach to regulatory affairs. This shows your genuine interest in the company and helps you assess if it’s the right fit for you.
