At a Glance
- Tasks: Support product development and regulatory submissions 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 culture to help you thrive.
- Why this job: Be part of a diverse team making a real impact on global health.
- Qualifications: Degree educated with a background in CMC functions; no prior regulatory experience needed.
The predicted salary is between 40000 - 50000 £ per year.
Career Category Regulatory
Job Description
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.
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 employer: Amgen Inc. (IR)
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, while our flexible working arrangements in modern offices in Uxbridge and Cambridge allow for a healthy work-life balance. Join us to be part of a mission-driven team dedicated to serving patients and making a meaningful impact in the world.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Associate Regulatory Affairs - CMC
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Amgen. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Brush up on CMC processes and be ready to discuss how your background fits into the regulatory landscape.
✨Tip Number 3
Show your passion for patient care! During interviews, share why you’re excited about working in regulatory affairs and how you can contribute to Amgen's mission.
✨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.
We think you need these skills to ace Sr Associate Regulatory Affairs - CMC
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 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 tackled new challenges or learned something new in a fast-paced environment.
Apply Through Our Website:Don’t forget to apply directly through our careers page! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity.
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 frameworks and processes that govern product development and registration. This will show your familiarity with the role and help you speak confidently about how you can contribute.
✨Prepare for Scenario Questions
Expect to be asked about specific scenarios related to regulatory submissions and project management. Think of examples from your past experiences where you successfully navigated challenges or led projects. Use the STAR method (Situation, Task, Action, Result) to structure your responses clearly.
✨Show Your Collaborative Spirit
Since this role involves working with various teams, be ready to discuss how you’ve collaborated in the past. Highlight your ability to communicate effectively with different stakeholders, including authors and subject matter experts. Share examples that demonstrate your teamwork skills and adaptability.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions prepared. Inquire about the team dynamics, ongoing projects, or how success is measured in the role. This not only shows your interest but also helps you gauge if the company culture aligns with your values.
