At a Glance
- Tasks: Lead regulatory activities for clinical trials and provide strategic guidance across development programmes.
- Company: Join a leading global biotechnology organisation with a focus on innovation.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Contract role with immediate start; must be UK-based and near West London.
- Why this job: Make a real impact in the biotech field while advancing your regulatory expertise.
- Qualifications: Master's degree in Life Sciences and 5+ years in Regulatory Affairs required.
The predicted salary is between 70000 - 90000 £ per year.
Job Title
Senior Manager, Regulatory Affairs/ Consultant (CTAs)
Job Type
12-Month Contract
Location
- West London, UK – Hybrid
- ***Please note that this is a 12 Month Contract opportunity***
Cpl Life Sciences is partnering with a leading global biotechnology organisation to recruit an experienced Senior Manager, Regulatory Affairs to support a growing portfolio of clinical development programmes across Immunology, Inflammation and Genetics.
This is an exciting opportunity for a regulatory professional with strong European clinical regulatory expertise to take ownership of clinical trial applications, support the start-up of new studies, and provide strategic regulatory leadership across multiple development programmes.
The successful candidate will work closely with global development teams and oversee interactions with external CRO partners to ensure regulatory excellence throughout the clinical trial lifecycle.
Key Responsibilities
- Act as a key regulatory expert for Europe, strengthening the organisation's regulatory presence and providing regional expertise to global regulatory and development teams.
- Lead all regulatory activities associated with clinical trial start-up and maintenance across Europe, including:
- Clinical Trial Applications (CTAs)
- Regulatory submissions and amendments
- Responses to health authority questions
- Compliance and regulatory maintenance activities
- Partner with clinical and cross-functional teams to ensure timely study initiation and ongoing study conduct.
- Represent the organisation in interactions with multiple Contract Research Organisations (CROs) supporting a diverse portfolio of clinical studies.
- Identify and leverage innovative European regulatory pathways and opportunities to accelerate development programmes.
- Provide strategic regulatory guidance across both early-stage and late-stage clinical development programmes.
- Monitor and interpret emerging EU regulations, legislation and guidance, ensuring organisational awareness and compliance where applicable.
- Collaborate with the Senior Director of Regulatory Affairs and broader leadership team to support programme progression and key development milestones.
- Contribute to continuous improvement of regulatory processes and ways of working across the organisation.
- Candidate Profile
- Master's Degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline.
- Minimum 5 years' experience within Regulatory Affairs, ideally within the biotechnology or pharmaceutical industry.
- Strong experience supporting European clinical development programmes and clinical trial applications.
- Thorough understanding of EU clinical trial regulations, regulatory frameworks and submission processes.
- Experience working with CRO partners and managing external regulatory activities.
- Proven ability to work independently and lead regulatory activities across multiple programmes.
- Experience supporting both early- and late-phase clinical development would be highly advantageous.
- Strong stakeholder management and communication skills, with the ability to influence cross-functional teams.
Please note that this is a contract role, looking for someone to start ASAP so please ensure you have a maximum of a 4-week notice.
Anyone with a longer notice period won’t be considered.
You MUST also be based in the UK and within a commutable distance to the UK office in West London.
For more information, please contact
Senior Manager, Regulatory Affairs/ Consultant (CTAs) in London employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the vibrant streaming and entertainment sector. Employees benefit from immediate project impact opportunities, comprehensive training, and career growth in a cloud-oriented environment, making it an ideal place for those looking to advance their skills in data engineering while working with cutting-edge technologies.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Affairs/ Consultant (CTAs) in London
✨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 Cpl 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 Cpl 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 Senior Manager, Regulatory Affairs/ Consultant (CTAs) in London
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 Cpl 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 Cpl 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 Cpl 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 Cpl Life Sciences.
How to prepare for a job interview at Cpl 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 Cpl 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.