At a Glance
- Tasks: Lead regulatory strategy and manage Clinical Trial Applications for innovative oncology therapies.
- Company: Join a leading global life sciences organisation making a real impact in healthcare.
- Benefits: 12-month contract, hybrid working, and opportunities for extension and career growth.
- Other info: Flexible working arrangements for the right candidate in a high-impact role.
- Why this job: Be at the forefront of cutting-edge oncology programmes in a collaborative environment.
- Qualifications: Experience in Regulatory Affairs with strong knowledge of EU regulations and clinical development.
The predicted salary is between 60000 - 80000 £ per year.
An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to support innovative oncology and advanced therapy programmes within a global biopharmaceutical environment.
This role will play a key part in driving regulatory strategy, leading Clinical Trial Applications (CTA), EU CTR submissions, substantial amendments, and broader regulatory activities across EU.
Working closely with global and regional stakeholders, you will support the development of cutting-edge therapies in a fast-paced, highly collaborative setting.
Key Responsibilities
Lead regulatory affairs activities for development-stage and marketed products.
Drive CTA submissions, amendments and EU CTR activities across Europe.
Develop and execute regulatory strategy in partnership with global regulatory teams.
Prepare and coordinate regulatory submissions in line with EU and ICH requirements.
Represent Regulatory Affairs within cross-functional project teams.
Monitor evolving European regulatory requirements and provide strategic guidance to stakeholders.
Experience Required
Proven experience within Regulatory Affairs in the pharmaceutical or biotech sector.
Strong knowledge of Clinical Trial Applications (CTA) and the EU Clinical Trials Regulation (EU CTR).
Experience developing and executing regulatory strategy for clinical development programmes.
Broad understanding of European regulatory requirements and procedures.
Experience supporting interactions with health authorities and cross-functional teams.
Oncology, cell therapy, ATMP or advanced therapy experience would be highly advantageous.
What's on Offer?
12-month contract with a leading global life sciences organisation, scope to extend.
Opportunity to support innovative oncology programmes and complex regulatory strategy activities.
Hybrid working with flexibility for the right candidate.
High-impact role working across Regulatory Affairs, clinical development and global project teams.
Please reach out and apply now if you'd like to hear more.
Regulatory Affairs, Regulatory Manager, Regulatory Strategy, Oncology, CTA, Clinical Trial Applications, EU CTR, EU Clinical Trials Regulation, Advanced Therapies, ATMP, Cell Therapy, Clinical Development, Europe, Regulatory Submissions
Regulatory Affairs Manager Oncology CTA in Cambridge employer: Hays Life Sciences
Join a leading healthcare organisation that values innovation and collaboration, offering a dynamic work environment where you can take ownership of life cycle strategy across a diverse EU portfolio. With flexible working options and a strong focus on employee growth, this company fosters a culture of continuous improvement and support, making it an excellent employer for those looking to make a meaningful impact in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager Oncology CTA in Cambridge
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like Hays Life Sciences who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at Hays Life Sciences, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace Regulatory Affairs Manager Oncology CTA in Cambridge
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Hays Life Sciences as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at Hays Life Sciences.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Hays Life Sciences. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Hays Life Sciences.
How to prepare for a job interview at Hays Life Sciences
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at Hays Life Sciences aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
