At a Glance
- Tasks: Lead regulatory projects and support product development in a dynamic biotech environment.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Flexible work options, generous rewards, and opportunities for personal and professional growth.
- Other info: Comprehensive training and a supportive team culture await you.
- Why this job: Make a real impact in healthcare while collaborating with diverse teams on innovative projects.
- Qualifications: Degree educated with a background in CMC functions; project management skills are a plus.
The predicted salary is between 40000 - 50000 £ 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
- 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 their 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.
Be part of our team
You will be joining a supportive and diverse team, where comprehensive regulatory training is provided, alongside a buddy system and exposure to a wide variety of projects and therapy areas. The Regulatory Optimization of Technical, Surveillance, and Strategic Support (ROOTS2) group within RA CMC, supports CMC submission execution for Amgen products across phases of development, modality and countries.
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:
- 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
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.
LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
APPLY NOW for a career that defies imagination. In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement: 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 Uxbridge employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that values collaboration and innovation. Our supportive and diverse work culture fosters professional growth through comprehensive training and a buddy system, ensuring that every team member can thrive in their role. With flexible working options from our state-of-the-art Cambridge or Uxbridge locations, we offer generous benefits that prioritise your well-being and career development, making Amgen an exceptional employer for those looking to make a meaningful impact in the healthcare industry.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Associate Regulatory Affairs - CMC 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.
✨Tip Number 3
Practice your STAR technique for behavioural questions. Think of specific situations where you demonstrated your skills in project management or teamwork. This will help you stand out during the interview.
✨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 Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Sr Associate Regulatory Affairs role. Highlight any CMC-related functions you've been involved in, even if your experience in Regulatory Affairs is limited.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're excited about this position at Amgen. Share specific examples of how your background makes you a great fit for the team and how you can contribute to our mission of serving patients.
Showcase Your Communication Skills:Since strong written communication is key for this role, ensure your application is clear, concise, and free of errors. This is your chance to demonstrate your ability to communicate effectively, just like you would in the job!
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 and shows us you’re serious about joining our team at Amgen.
How to prepare for a job interview at Amgen
✨Know Your CMC Basics
Before the interview, brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC). Understand the key regulatory processes and how they impact product development. This will show that you’re not just familiar with the terms but can engage in meaningful discussions about them.
✨Showcase Your Project Management Skills
Be ready to discuss specific examples of how you've managed projects in the past. Highlight your organisational skills and how you’ve successfully navigated challenges. This is crucial as the role involves leading projects and maintaining timelines.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since strong oral and written communication skills are essential for this role, consider preparing a few key points about your experience that you can share confidently during the interview.
✨Demonstrate Curiosity and Proactivity
Amgen values curiosity and a proactive approach. Prepare questions that show your interest in the company’s mission and the role itself. This could be about their regulatory strategies or how they handle cross-functional projects. It’ll reflect your eagerness to learn and contribute.
