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- Tasks: Lead regulatory projects and collaborate with global teams to support product development.
- Company: Join a leading biotechnology company dedicated to improving patient lives.
- Benefits: Generous rewards plan, health benefits, work/life balance, and career growth opportunities.
- Other info: Be part of a diverse community that values your ideas and contributions.
- Why this job: Make a real impact in biotechnology while growing your career in a supportive environment.
- Qualifications: Relevant degree and experience in manufacturing, quality assurance, or regulatory affairs.
The predicted salary is between 36000 - 60000 £ per year.
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.
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 the product lifecycle.
Amgen is searching for a Senior Associate to join the Regulatory Optimization of Technical, Surveillance, and Strategic Support (ROOTS2) group within RA CMC. You will be responsible for varying levels of product support, including leading projects, based upon your experience level.
- 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
- Interface with the regulatory operations team
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
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.
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.
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.
Senior Associate Regulatory Affairs in Cambridge employer: Amgen
Contact Detail:
Amgen 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 employees at Amgen or in the regulatory affairs field. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory CMC processes. We recommend practising common interview questions and having examples ready that showcase your project management skills and experience.
✨Tip Number 3
Show your passion for biotechnology! During interviews, let your enthusiasm for the industry shine through. Talk about how you can contribute to Amgen's mission of improving patient lives with your expertise.
✨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 the 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 is tailored to the Senior Associate Regulatory Affairs role. Highlight your relevant experience in regulatory CMC, project management, and any specific skills that match the job description. We want to see how you can contribute to our team!
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 makes you a perfect fit for our ROOTS2 group. Let us know what excites you about working with us at Amgen.
Showcase Your Team Spirit: We’re all about collaboration here at StudySmarter. In your application, share examples of how you've worked effectively in teams, especially in cross-functional projects. We love to see candidates who thrive in a diverse and inclusive environment!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensure it gets the attention it deserves. 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 a candidate, but someone who is genuinely interested in the field.
✨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, resources, and team dynamics. Highlight how you’ve contributed to cross-functional teams and what strategies you used to keep everyone aligned.
✨Engage with the Team
During the interview, don’t just answer questions—engage with your interviewers. Ask insightful questions about the ROOTS2 group and how they collaborate on regulatory submissions. This shows that you’re not only interested in the position but also in how you can contribute to the team’s success.
✨Demonstrate Your Adaptability
The biotechnology field is ever-evolving, so it’s crucial to demonstrate your adaptability. Share experiences where you had to pivot or adjust your approach due to new information or changing circumstances. This will highlight your ability to thrive in a dynamic environment, which is key for a Senior Associate in Regulatory Affairs.