At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for innovative medicines across Europe.
- Company: Leading global biotechnology organisation with a high-performing team.
- Benefits: Competitive hourly rate, hybrid work model, and opportunity for professional growth.
- Other info: Flexible working with occasional travel; must have right to work in the UK.
- Why this job: Join a dynamic team and make a real impact on the future of healthcare.
- Qualifications: Scientific degree and experience in Regulatory Affairs within pharma or biotech.
The predicted salary is between 47.41 - 47.41 £ per hour.
PE Global is currently recruiting for a Regulatory Affairs Manager on behalf of a leading global biotechnology organisation. This is an excellent opportunity to join a high-performing European Regulatory Affairs team supporting innovative medicines from early clinical development through to commercialisation. This hybrid position offers the flexibility to work primarily from home, with occasional travel to the Cambridge or Uxbridge office as required.
Contract Duration: 12 months
Rate: £47.41 per hour PAYE or £55.56 per hour Umbrella
The Role
As the Regulatory Affairs Manager, you will play a key role in ensuring products obtain and maintain the necessary regulatory approvals to support both clinical development and commercial marketing across Europe. Working within a collaborative international regulatory team, you will contribute to regulatory strategy, submissions, and lifecycle management across a diverse product portfolio.
Key Responsibilities
- Plan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation activities, in line with global strategies and regional requirements.
- Support the implementation of regulatory strategies and regulatory affairs activities for assigned products.
- Provide regulatory guidance on regional submission requirements and regulatory pathways.
- Contribute to the preparation of regional regulatory documentation and support interactions with regulatory authorities.
- Support regional labelling negotiations and lifecycle management activities.
- Participate in the development and execution of regional regulatory strategies.
- Assess regulatory risks and help develop mitigation plans.
- Monitor changes in regulatory legislation, guidance and policy across the region.
- Conduct regulatory research to support product development and registration activities.
- Evaluate the impact of evolving regulatory requirements and competitor activities on product strategy.
Candidate Requirements
- A scientific degree or equivalent qualification.
- Demonstrated experience within Regulatory Affairs in the pharmaceutical or biotechnology industry.
- Strong understanding of regulatory legislation, policies, procedures and SOPs relating to medicinal products.
- Knowledge of regional regulatory procedures for clinical trials, marketing authorisations, post-approval variations, renewals and extensions.
- Good understanding of the drug development process.
- Experience working within the European regulatory environment.
- Excellent written and verbal communication skills.
- Ability to interpret and communicate scientific and clinical information effectively.
- Strong analytical and problem-solving skills with the ability to anticipate regulatory challenges and develop practical solutions.
- Excellent stakeholder management and collaboration skills.
Please note: Our client cannot provide visa sponsorship. Applicants must already have the legal right to live and work in the UK. Interested candidates should submit an updated CV for immediate consideration.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager/Director of Regulatory Affairs 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 PE Global 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 PE Global, 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/Director of Regulatory Affairs 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 PE Global 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 PE Global.
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 PE Global. 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 PE Global.
How to prepare for a job interview at PE Global
✨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 PE Global 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.
