At a Glance
- Tasks: Take ownership of regulatory documents and coordinate with teams on oncology programmes.
- Company: Join a leading international clinical research organisation with a collaborative culture.
- Benefits: Fully remote work available, strong career growth, and exposure to diverse projects.
- Other info: Enjoy a dynamic environment with direct sponsor interaction and a visible role.
- Why this job: Make a real impact in oncology while managing exciting regulatory documentation.
- Qualifications: 5+ years in regulatory writing, especially in oncology, with strong communication skills.
The predicted salary is between 60000 - 75000 € per year.
An international clinical research organisation is looking to appoint a Senior Regulatory Writer to join its growing regulatory writing team.
This role would suit an experienced regulatory writing professional who enjoys working across complex clinical development programmes and wants to play a visible role supporting sponsor-facing regulatory activities within a collaborative CRO environment.
The team is looking for someone who is confident managing regulatory documentation independently, comfortable coordinating across multiple stakeholders and able to contribute strategically across the wider submission process.
The opportunity
You’ll take ownership of a broad range of regulatory and clinical documents across oncology programmes, supporting studies throughout different stages of development and submission activity.
Alongside document preparation, you’ll work closely with sponsors, medical teams and operational colleagues to coordinate timelines, manage review cycles and ensure documentation is aligned with regulatory expectations and project objectives.
The role offers strong exposure across cross-functional teams and would suit someone who enjoys balancing scientific accuracy, organisation and stakeholder management within a fast-moving environment.
Experience they’re hoping to see
- 5+ years’ experience within a CRO, biotech or pharmaceutical environment
- Strong background in regulatory writing within oncology
- Experience leading the preparation of regulatory documentation including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, IND applications and DSURs
- Familiarity with Fast Track Applications and accelerated submission pathways
- Experience coordinating sponsor reviews, timelines and document workflows
- Understanding of eCTD structures and regulatory submission requirements
- Ability to manage multiple projects simultaneously and work independently
- Strong written communication and stakeholder management skills
- A highly organised and detail-focused approach
What makes this opportunity interesting
- Broad involvement across oncology-focused regulatory programmes
- Client-facing exposure with direct sponsor interaction
- Opportunity to contribute across the full regulatory documentation lifecycle
- Visible role within a growing regulatory writing group
- Fully remote working available across the UK
Apply now.
For more information, please contact Nicky Stunt, Principal Healthcare Communications Recruiter.
Senior Regulatory Medical Writer in Luton employer: RBW Consulting
Join a leading international clinical research organisation that values collaboration and innovation in the regulatory writing field. With a strong focus on oncology programmes, this role offers the chance to work remotely across the UK, providing you with flexibility while engaging in meaningful projects that directly impact patient outcomes. The company fosters a supportive work culture that encourages professional growth and development, making it an excellent employer for those looking to advance their careers in regulatory writing.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Medical Writer in Luton
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in regulatory writing or clinical research. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of oncology and regulatory processes. We recommend practising common interview questions and scenarios related to document preparation and stakeholder management to show you're the right fit.
✨Tip Number 3
Showcase your experience! When you get the chance to speak with potential employers, highlight your past projects and how you've successfully managed timelines and documentation. This will demonstrate your ability to handle the responsibilities of the role.
✨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, it shows you’re genuinely interested in joining our team and contributing to exciting oncology programmes.
We think you need these skills to ace Senior Regulatory Medical Writer in Luton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your regulatory writing experience, especially in oncology, to show us you’re the right fit for the role.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you’re passionate about regulatory writing and how your background aligns with our needs. Be sure to mention any relevant projects or achievements that demonstrate your expertise.
Showcase Your Communication Skills:Since this role involves coordinating with multiple stakeholders, make sure your application showcases your strong written communication skills. Use clear and concise language to convey your points effectively.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process.
How to prepare for a job interview at RBW Consulting
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory writing, especially in oncology. Be ready to discuss specific documents like Clinical Study Protocols and IND applications. Showing that you understand the nuances of these documents will impress the interviewers.
✨Showcase Your Project Management Skills
Since this role involves managing multiple projects and coordinating with various stakeholders, be prepared to share examples of how you've successfully juggled similar responsibilities in the past. Highlight your organisational skills and ability to meet tight deadlines.
✨Demonstrate Your Communication Prowess
Strong written and verbal communication skills are key for this position. Practice articulating your thoughts clearly and concisely. You might even want to prepare a brief presentation on a relevant topic to showcase your ability to convey complex information effectively.
✨Be Ready for Scenario Questions
Expect questions that assess how you would handle real-world situations, such as coordinating timelines or managing sponsor reviews. Think through potential scenarios beforehand and have a few strategies in mind to demonstrate your problem-solving abilities.
