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For Companies At a Glance
- Tasks: Join a team that drives product development and regulatory strategies in biotechnology.
- Company: Amgen, a leading global biotechnology company focused on serving patients.
- Benefits: Generous rewards plan, career growth opportunities, and a supportive work environment.
- Why this job: Make a real impact in healthcare while collaborating with diverse teams.
- Qualifications: Bachelor’s degree and experience in manufacturing or regulatory affairs required.
- Other info: Dynamic workplace with vast learning opportunities and a culture of inclusion.
The predicted salary is between 36000 - 60000 ÂŁ 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. 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 Uxbridge employer: Amgen SA
Contact Detail:
Amgen SA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr Associate Regulatory Affairs - CMC (x2) in Uxbridge
✨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 of serving patients.
✨Tip Number 3
Practice makes perfect! Get a friend to do mock interviews with you. Focus on articulating your experience in regulatory affairs and how it aligns with the role. Confidence is key!
✨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 Amgen team and contributing to their innovative work.
We think you need these skills to ace Sr Associate Regulatory Affairs - CMC (x2) in Uxbridge
Some tips for your application 🫡
Show Your Passion: When you're writing your application, let your enthusiasm for the role shine through. We want to see how your passion for regulatory affairs and patient care aligns with our mission at Amgen.
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in CMC and regulatory affairs. We love seeing how your unique background fits into the role, so don’t hold back on showcasing your skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to tell us why you’re the perfect fit for the Senior Associate position. Be specific about your experiences and how they relate to the responsibilities outlined in the job description.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently, so don’t miss out on this opportunity!
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 global 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
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 handle timelines and coordinate with cross-functional teams, 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 That Matter
Think of insightful questions to ask your interviewers about the ROOTS2 team and their current projects. This shows your genuine interest in the role and helps you understand how you can fit into their mission. Questions about team dynamics or upcoming challenges can spark engaging conversations.
