At a Glance
- Tasks: Lead regulatory strategies for biosimilars and manage submissions in compliance with EU regulations.
- Company: Join Amgen, a leader in biotechnology with a commitment to innovation.
- Benefits: Enjoy growth opportunities, a diverse community, and a generous rewards plan.
- Other info: Collaborative culture where your ideas are valued and career growth is encouraged.
- Why this job: Make a real impact in drug development while working in a dynamic environment.
- Qualifications: Degree in a scientific discipline 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.
- 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.
- Consistent with GRT strategy, 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) in London employer: Amgen
Amgen is an exceptional employer, offering a dynamic and inclusive work culture that empowers employees to contribute their unique ideas while driving innovation in the biosimilars sector. 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 overall well-being.
StudySmarter Expert Advice🤫
We think this is how you could land EU Regulatory Affairs Senior Manager (Biosimilars) in London
✨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 specific strategies you've implemented in past roles and how they align with Amgen's goals.
✨Tip Number 3
Showcase your leadership skills! During interviews, highlight examples where you led teams or projects successfully. This will demonstrate your ability to thrive in a dynamic environment, just like the one at Amgen.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in being part of our diverse and inclusive community.
We think you need these skills to ace EU Regulatory Affairs Senior Manager (Biosimilars) in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in the biosimilars regulatory environment. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!
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 your skills can contribute to our team. Keep it engaging and personal – we love to see your personality come through.
Showcase Your Problem-Solving Skills:In your application, give examples of how you've tackled challenges in regulatory processes. We’re looking for proactive problem solvers who can navigate the complexities of the biosimilars landscape, so share those success stories!
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, you’ll get to explore more about what we do at StudySmarter!
How to prepare for a job interview at Amgen
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU regulations regarding biosimilars. Familiarise yourself with the specific registration procedures and compliance requirements. This will show that you're not just knowledgeable but also genuinely interested in the role.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or lead a team through a complex submission process. Think of examples from your past experience where you successfully navigated similar situations, and be ready to discuss them in detail.
✨Show Your Collaborative Spirit
Since this role involves working with various stakeholders, be prepared to discuss how you've effectively collaborated in previous roles. Highlight instances where you led teams or worked cross-functionally to achieve regulatory goals, showcasing your ability to foster teamwork.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to regulatory strategy or how they handle interactions with health authorities. This demonstrates your enthusiasm for the role and helps you gauge if the company is the right fit for you.
