At a Glance
- Tasks: Lead regulatory projects and collaborate with global teams to support product development.
- Company: Join a leading biotechnology company dedicated to improving patient lives worldwide.
- Benefits: Generous rewards plan, health benefits, work/life balance, and career growth opportunities.
- Other info: Be part of a diverse community that values innovation and teamwork.
- Why this job: Make a real impact in biotechnology while growing your career in a supportive environment.
- Qualifications: Bachelor's degree and experience in manufacturing or regulatory affairs required.
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 Specialist, Regulatory Affairs in Cambridge employer: Amgen
Amgen is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. With a strong commitment to employee growth, Amgen provides generous benefits and a supportive culture that values diversity and inclusion, ensuring that every team member can contribute meaningfully to the development of life-changing biotechnological products. Located in a vibrant community, employees enjoy a balanced work/life experience while being part of a global team dedicated to improving patient outcomes worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist, Regulatory Affairs in Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CMC regulations and recent industry trends. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific projects you've led or contributed to, especially those related to regulatory submissions. We want to see how you can bring value to our team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see what you can bring to the table, so make sure you put your best foot forward!
We think you need these skills to ace Senior Specialist, Regulatory Affairs in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Specialist, Regulatory Affairs role. Highlight your relevant experience in regulatory CMC and any project management skills you have. We want to see how your background aligns with what we're looking for!
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 you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Team Spirit:Since we value collaboration, make sure to highlight any experiences where you've worked effectively in teams. Share examples of how you've contributed to group projects or supported colleagues in achieving common goals.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our community!
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 regulations and guidelines 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
Be ready to discuss your experience with project management and how you've successfully led projects in the past. Prepare specific examples that highlight your organisational skills and ability to manage cross-functional teams. This will demonstrate that you can handle the responsibilities of the role effectively.
✨Engage with the Team
During the interview, make an effort to engage with your interviewers. Ask insightful questions about the team dynamics and how they collaborate on regulatory submissions. This shows that you’re not only interested in the role but also in being a part of their collaborative culture.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities in regulatory affairs. Think of situations where you had to navigate complex regulatory challenges and be prepared to explain your thought process. This will help the interviewers see how you approach real-world issues in the field.
