At a Glance
- Tasks: Ensure compliance with EU regulations for clinical trials and medicinal products.
- Company: Join a leading biotechnology company making a global impact.
- Benefits: Flexible remote work, generous rewards, and growth opportunities.
- Other info: Diverse and inclusive workplace focused on personal and professional growth.
- Why this job: Be part of a team that shapes the future of healthcare.
- Qualifications: Degree educated with experience in regulatory affairs.
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.
What you will do
In this vital role you will work to ensure that Amgen acquires and maintains all the required EU licenses in order to support clinical trials for investigational medicinal products as well as marketed medicinal products. You will support one or more products from an EU regulatory perspective.
Strategy and Execution
Depending on business needs and experience, the role may include EU Regulatory Lead responsibility for one or more products. 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 EU regional regulatory requirements. Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with EU regional 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, scientific advice, Orphan Drug, MA approval mechanisms and paediatric plans). 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
We are currently looking for x3 EU Regulatory Affairs Managers between Portugal and the United Kingdom, joining the EU Oncology or General Medicine teams, 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.
Qualifications
- Degree educated and previous experience in a similar role
- Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA regulatory procedures (e.g. scientific advice, orphan applications or Paediatric Investigation Plans (PIPs)), MA, post-approval changes, extensions and renewals
- Experience developing regulatory strategies for products in clinical development and post-marketing phases.
- Knowledge of EU legislation and regulations relating to medicinal products
- Working with policies, procedures and SOPs.
What you can expect of us
As we work to develop treatments that take care of others, 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.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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.
United Kingdom - Remote; Portugal - Remote; United Kingdom - Edinburgh
Type: Full time
Compliance Manager in Cambridge employer: Amgen
Amgen in Uxbridge is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharmaceutical sector. Employees benefit from comprehensive professional development opportunities, competitive compensation, and a commitment to quality and compliance that empowers them to make a meaningful impact on clinical trials. With a focus on employee well-being and a supportive environment, Amgen stands out as a rewarding place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land Compliance Manager in Cambridge
✨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. 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!
We think you need these skills to ace Compliance Manager in Cambridge
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 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.
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 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
✨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. 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'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. This shows your passion for the industry!
