At a Glance
- Tasks: Lead regulatory strategies for biosimilars and ensure compliance with European regulations.
- Company: Join Amgen, a leader in biotechnology with a commitment to innovation.
- Benefits: Enjoy a generous rewards plan, health benefits, and opportunities for career growth.
- Other info: Be part of a diverse community that values your unique contributions.
- Why this job: Make a real impact in drug development while working in a dynamic, collaborative environment.
- Qualifications: Degree in a scientific field and extensive experience in biosimilars regulatory affairs.
The predicted salary is between 70000 - 90000 £ per year.
In this vital role you will work to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of European regulatory strategies, submissions, and plans.
Responsibilities include:
- Plan and manage regulatory submissions for products within Amgen's biosimilar portfolio in compliance with global filing plans and local regulatory requirements.
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
- Lead development of regional regulatory documents and meetings in accordance with GRT strategy.
- Provide regulatory direction on regional regulatory mechanisms to optimize product development.
- Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
- Advise on regulatory implications and requirements related to regional development plans and objectives.
- Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately.
- Ensure and lead regulatory compliance for biosimilar products (eg, agency commitments).
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning.
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 in a scientific discipline.
- Extensive experience of the regional Biosimilars regulatory environment.
- Proven track record of developing and executing regional Biosimilars regulatory strategy.
- In-depth understanding of the drug life cycle and development process from a regulatory perspective.
- In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Ability to lead teams and work collaboratively in a dynamic environment.
- Proactive approach to problem solving.
- Ability to understand and communicate scientific/clinical information.
- Ability to anticipate regulatory agency expectations.
- Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development.
What you can expect of us:
- 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.
EU Regulatory Affairs Senior Manager (Biosimilars) employer: Amgen
Amgen is an exceptional employer, offering a dynamic work environment where innovation thrives and employees are encouraged to contribute their unique perspectives. With a strong focus on professional growth, Amgen provides ample opportunities for career advancement within its global organisation, alongside a generous Total Rewards Plan that supports health, work/life balance, and financial well-being. Located in a diverse and inclusive community, Amgen fosters collaboration and empowers its team members to drive meaningful change in the biosimilars sector.
StudySmarter Expert Advice🤫
We think this is how you could land EU Regulatory Affairs Senior Manager (Biosimilars)
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience with biosimilars. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of the EU regulatory landscape. Be ready to discuss how you would tackle specific challenges in biosimilars. Show them you’re not just a fit on paper but also in practice!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you note. It shows your enthusiasm and keeps you fresh in their minds. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen. Plus, you’ll be part of a community that values diverse perspectives and innovative ideas in regulatory affairs.
We think you need these skills to ace EU Regulatory Affairs Senior Manager (Biosimilars)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of EU Regulatory Affairs Senior Manager. Highlight your experience in biosimilars and regulatory strategies, as this will show us you understand what we're looking for.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past successes in regulatory affairs and how they relate to our needs at Amgen.
Showcase Your Teamwork Skills:We value collaboration, so be sure to mention any experiences where you've successfully led teams or worked with others in a dynamic environment. This will help us see how you can contribute to our community.
Apply Through Our Website:Don't forget to apply 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 us you're keen on joining our team!
How to prepare for a job interview at Amgen
✨Know Your Regulatory Stuff
Make sure you brush up on the EU regulatory environment, especially around biosimilars. Be ready to discuss specific regulations and how they impact product development. This shows you’re not just familiar with the theory but can apply it practically.
✨Showcase Your Strategic Thinking
Prepare examples of how you've developed and executed regulatory strategies in the past. Think about challenges you faced and how you overcame them. This will demonstrate your ability to think critically and strategically, which is key for this role.
✨Communicate Clearly
Practice explaining complex scientific and regulatory concepts in simple terms. You might need to interact with various stakeholders, so being able to communicate effectively is crucial. Consider doing mock interviews to refine your communication skills.
✨Be Proactive and Problem-Solving
Think of instances where you anticipated regulatory agency expectations or solved problems before they escalated. Highlighting your proactive approach will resonate well with interviewers looking for someone who can navigate the dynamic regulatory landscape.
