At a Glance
- Tasks: Drive regulatory strategies for biosimilars, managing submissions and compliance across Europe.
- 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: Be part of a diverse community that values your unique contributions.
- Why this job: Make a real impact in healthcare while collaborating with global teams on innovative projects.
- Qualifications: Degree educated with experience in EU biosimilar submissions and strong communication skills.
The predicted salary is between 63000 - 77000 £ 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.
- EU REGULATORY AFFAIRS MANAGER - BIOSIMILARS
- LIVE
What you will do
In this vital role you will contribute to the development and execution of European regulatory strategies for Amgen's biosimilar portfolio, supporting products from development and registration through launch and lifecycle management.
- Plan and manage EU/EEA regulatory submissions, including MAAs, responses to Health Authorities, CTAs/CTIS activities and post-approval lifecycle submissions.
- Partner with global and regional cross-functional teams, including CMC, Clinical, Safety, Quality, Legal and Commercial.
- Lead and support Health Authority interactions, including preparation of briefing materials, regulatory responses and follow-up actions.
- Support product information and labelling activities, including Sm PC, Package Leaflet, artwork and regional label negotiations.
- Ensure regulatory compliance and maintenance of filings throughout development and the product lifecycle.
- Monitor evolving EU biosimilar legislation, guidance, regulatory policy and competitor intelligence, assessing potential impact on regulatory strategies.
- Contribute to regulatory processes, SOPs, templates and continuous improvement initiatives.
- Be part of our team
We are currently looking for a Regulatory Affairs Manager based in either Portugal or the United Kingdom.
You would be joining the European Regulatory Team, part of the Global Regulatory Affairs function in Europe.
You would be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from clinical trials to marketing authorisation, and throughout the products lifecycle.
- WIN
- 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.
- Knowledge of drug development for Biosimilars within a regional regulatory environment including direct experience with EU biosimilar submissions and post-approval maintenance.
- Proven experience working with policies, procedures and SOP's.
- Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
- Experience with EU Centralised Procedure and understanding of EU regulatory incentives.
- Strong communication skills - both oral and written.
- Ability to anticipate and prevent potential issues.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
- Experience in a global or matrixed organization with collaboration across multiple regions.
- THRIVE
- 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, Uxbridge or Lisbon office.
The expected gross pay range for this role in Portugal is EUR 48,957.00 to EUR 66,237.00.
Actual pay will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
For candidates based in the UK, compensation will be aligned with the local market and role requirements, with further details discussed during the recruitment process.
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.
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EU Regulatory Affairs Manager (Biosimilars) employer: Amgen SA
Amgen is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the life sciences sector. With a strong commitment to employee growth, you will have access to extensive training and development opportunities while working remotely from the UK or US, allowing for a flexible work-life balance. Join us to be part of a team that values quality and process improvement in clinical trials, making a meaningful impact on global healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land EU Regulatory Affairs Manager (Biosimilars)
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Amgen SA. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Amgen SA!
We think you need these skills to ace EU Regulatory Affairs Manager (Biosimilars)
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Amgen SA that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Amgen SA.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Amgen SA does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Amgen SA
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Amgen SA. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Amgen SA's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Amgen SA. This shows your passion for the industry!
