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For Companies At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for clinical trials and approved products.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Enjoy flexible work options, generous rewards, and opportunities for personal and professional growth.
- Why this job: Make a real impact in healthcare by supporting innovative treatments and navigating regulatory landscapes.
- Qualifications: Scientific degree and experience in regulatory affairs with strong communication skills.
- Other info: Be part of a diverse team that values your unique contributions and ideas.
The predicted salary is between 36000 - 60000 £ 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 work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
- You will support one or more products from a regional regulatory perspective.
- Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
- Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
- Support regional label negotiation activities.
- Under general supervision participate in the development, and execution of regional regulatory product strategies.
- Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
Regulatory Research
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
- Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.
Be part of our team
You will be joining the European General Medicine Regulatory team, part of the Global Regulatory Affairs function in Europe. You will be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle. This team leads the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflammation, Endocrine and Bone disease areas, as well as pre-approval filing activities for Biosimilars.
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:
- Scientific Degree and demonstrated experience in a similar role.
- Regulatory principles.
- Working with policies, procedures and SOP’s.
- Knowledge of legislation and regulations relating to medicinal products.
- Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
- Knowledge of drug development.
- Knowledge of and experience in regional regulatory environment.
- Strong communication skills - both oral and written.
- Ability to understand and communicate scientific/clinical information.
- Ability to anticipate and prevent potential issues.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
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.
- Growth 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: Flexibility to work from home with few days per month working from our Cambridge or Uxbridge office.
APPLY NOW for a career that defies imagination.
Regulatory Affairs Manager in Cambridge employer: Amgen SA
Contact Detail:
Amgen SA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already at Amgen. A friendly chat can open doors and give you insider info on what they’re really looking for.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on regulatory affairs trends and Amgen’s products. Show them you’re not just another candidate but someone who’s genuinely interested in their mission.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources. The more comfortable you are talking about your experience and skills, the better you’ll come across.
✨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 Regulatory Affairs Manager in Cambridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Affairs Manager role. Highlight your relevant experience and skills that align with Amgen's mission and the specific requirements mentioned in the job description.
Showcase Your Knowledge: Demonstrate your understanding of regulatory principles and legislation in your application. Mention any specific experiences you have had with regulatory submissions or compliance, as this will show us you’re serious about the role.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's relevant. We appreciate a well-structured application that’s easy to read!
Apply Through Our Website: Don’t forget to submit your application through our official website! This ensures that your application goes directly to us and is reviewed promptly. Plus, it’s the best way to stay updated on your application status.
How to prepare for a job interview at Amgen SA
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines related to medicinal products. Familiarise yourself with Amgen's portfolio and be ready to discuss how your experience aligns with their regulatory strategies.
✨Showcase Your Communication Skills
As a Regulatory Affairs Manager, strong communication is key. Prepare examples of how you've effectively communicated complex scientific information in the past, whether in written documents or during meetings.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges. Think about potential issues you might face in the role and prepare your thought process on resolving them, demonstrating your proactive approach.
✨Research Amgen’s Culture
Understand Amgen's mission and values, especially their focus on serving patients. Be prepared to discuss how your personal values align with theirs and how you can contribute to their collaborative environment.
