At a Glance
- Tasks: Join a dynamic team to support regulatory strategies and product development.
- Company: Amgen, a leading biotechnology company focused on serving patients.
- Benefits: Flexible work options, generous rewards, and opportunities for personal growth.
- Other info: Diverse and inclusive community with comprehensive training and mentorship.
- Why this job: Make a real impact in healthcare while developing your career in a supportive environment.
- Qualifications: Degree educated with a background in CMC functions; no prior Regulatory Affairs experience needed.
The predicted salary is between 40000 - 50000 £ 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
- In this vital role you will interface with the Amgen global, international, site and biosimilars Regulatory Affairs, Chemistry, Manufacturing and Controls (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 your experience level.
- The 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.
- 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
- Degree educated.
- Background in CMC related functions (e.g., Quality, Manufacturing, etc) with limited or no prior Regulatory Affairs experience.
- Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast-paced learning environment.
- Developed project management and organizational skills.
- Strong and effective oral and written communication skills.
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.
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.
Sr Associate Regulatory Affairs - CMC in Cambridge employer: Amgen Inc. (IR)
At Amgen, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters professional growth and collaboration. With flexible working arrangements from our state-of-the-art offices in Cambridge or Uxbridge, employees benefit from comprehensive training, a supportive team environment, and a generous rewards plan that prioritises health, work-life balance, and career advancement. Join us in our mission to serve patients and be part of a community where your contributions truly matter.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Associate Regulatory Affairs - CMC 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! Dive deep into Amgen’s products and recent news in the biotech world. Showing that you’re genuinely interested can set you apart from other candidates.
✨Tip Number 3
Practice makes perfect! Get a friend to do mock interviews with you. Focus on articulating your experience in CMC and how it relates to 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 team at Amgen.
We think you need these skills to ace Sr Associate Regulatory Affairs - CMC in Cambridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Sr Associate Regulatory Affairs role. Highlight your relevant experience in CMC functions and any project management skills that align with what we're looking for.
Showcase Your Communication Skills:Since strong written communication is key for this role, ensure your application is clear and concise. Use professional language but let your personality shine through – we want to see who you are!
Highlight Your Curiosity:We love candidates who are curious and proactive! In your application, mention any instances where you've tackled new challenges or learned something new in a fast-paced environment. It shows you're ready to grow with us.
Apply Through Our Website:Don't forget to submit your application through our careers page! It's the best way to ensure it gets into the right hands and helps us get to know you better.
How to prepare for a job interview at Amgen Inc. (IR)
✨Know Your CMC Basics
Before the interview, brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC). Understand the key regulatory requirements and processes involved in product development and registration. This will help you speak confidently about how your background aligns with the role.
✨Showcase Your Project Management Skills
Be prepared to discuss specific examples of projects you've managed or contributed to. Highlight your organisational skills and how you've successfully navigated challenges in a fast-paced environment. This will demonstrate your readiness for the responsibilities of the Sr Associate position.
✨Communicate Effectively
Strong oral and written communication skills are crucial for this role. Practice articulating your thoughts clearly and concisely. Consider preparing a few key points about your experience that you can share during the interview to showcase your communication prowess.
✨Emphasise Your Curiosity and Proactivity
The job description mentions the importance of being curious and proactive. Think of instances where you've taken the initiative to learn something new or tackle a challenge. Sharing these experiences will show that you're not just reactive but also eager to contribute positively to the team.
