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For Companies At a Glance
- Tasks: Lead and support regulatory submissions for clinical trials across Europe.
- Company: Join a forward-thinking team in the pharmaceutical industry.
- Benefits: Fully remote work, competitive package, and flexible hours.
- Why this job: Make a real impact on meaningful clinical development projects.
- Qualifications: 4+ years in regulatory roles and experience with Clinical Trial Applications.
- Other info: Dynamic team environment with potential for contract extension.
The predicted salary is between 36000 - 60000 £ per year.
8+ Month FTC | Fully Remote (UK or Sweden)
Are you an experienced Regulatory Affairs professional looking for your next impactful contract role? We are seeking a Regulatory Affairs Manager to support a growing portfolio of clinical development activities. This is an excellent opportunity to join a forward-thinking team, work fully remotely, and play a key role in shaping regulatory strategies across Europe.
About the Role
As the Regulatory Affairs Manager, you will lead and support the planning, preparation, and submission of Clinical Trial Applications (CTAs) across Europe. You will collaborate closely with internal teams, CRO partners, and regulatory bodies to ensure timely and compliant submissions, while bringing your expertise to a portfolio of innovative clinical programs.
This is an 8-month+ fixed-term contract, with strong potential for extension.
Education Requirements
- Bachelor’s degree required, preferably in a life science discipline or equivalent.
What We’re Looking For
- 4+ years’ experience working in a regulatory role within clinical trials in the pharmaceutical or CRO industry.
- 5+ years’ experience strategically planning, compiling, and submitting European Clinical Trial Applications.
- Strong, hands-on experience with CTIS and IRAS, including full CTA preparation and submission.
- Previous experience working within a CRO environment is highly desirable.
- Exposure to national regulatory submissions, such as GMO and radiation safety applications, is preferred.
- Experience preparing County-specific ICFs is also beneficial.
Location & Working Model
- Fully remote role
- Candidates must be based in either the UK or Sweden
- Occasional travel may be required (minimal)
Why Join?
- Opportunity to support meaningful clinical development projects
- Work with a collaborative, dynamic team
- Flexible, remote working environment
- Competitive FTC package and immediate start availability
Regulatory Affairs Manager employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field. A quick chat can lead to insider info about job openings or even a referral, which can give you a leg up in the application process.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Clinical Trial Applications and regulatory strategies. We recommend practising common interview questions and scenarios related to your experience with CTIS and IRAS.
✨Tip Number 3
Showcase your expertise! During interviews, highlight specific projects where you’ve successfully led submissions or navigated complex regulatory environments. This will demonstrate your hands-on experience and strategic planning skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience in clinical trials and regulatory submissions, especially your hands-on work with CTAs and any CRO experience you've got.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific projects or achievements that align with the job description and show us your passion for regulatory affairs.
Showcase Your Skills: Don’t forget to showcase your skills in strategic planning and compliance. We want to see how you’ve successfully navigated regulatory processes in the past, so be specific about your contributions and outcomes.
Apply Through Our Website: We encourage you to apply through our website for a smooth application process. It’s the best way for us to receive your application and get you one step closer to joining our dynamic team!
How to prepare for a job interview at RBW Consulting
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of Clinical Trial Applications (CTAs) and the specific regulations in Europe. Familiarise yourself with CTIS and IRAS, as well as any recent changes in regulatory guidelines. This will show that you're not just experienced but also up-to-date with the latest in the field.
✨Showcase Your Collaboration Skills
Since this role involves working closely with internal teams and CRO partners, be ready to discuss examples of how you've successfully collaborated in the past. Highlight any experiences where you navigated complex team dynamics or managed stakeholder expectations effectively.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about potential issues that could arise during CTA submissions and prepare your responses. This will demonstrate your problem-solving skills and strategic thinking.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the role and the company. Inquire about their current projects, team dynamics, or how they approach regulatory challenges. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
