At a Glance
- Tasks: Lead the creation of regulatory documents for oncology programmes and manage timelines with stakeholders.
- Company: Join a dynamic international clinical research organisation with a collaborative culture.
- Benefits: Fully remote work, competitive salary, and opportunities for professional growth.
- Other info: Enjoy a visible role in a growing team with diverse project involvement.
- Why this job: Make a real impact in oncology while working closely with sponsors and medical teams.
- 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, at nicky.stunt@rbwconsulting.com
Senior Regulatory Medical Writer employer: RBW Consulting
Join an international clinical research organisation that values collaboration and innovation, offering a dynamic work culture where your expertise in regulatory writing will be recognised and rewarded. With strong opportunities for professional growth and the flexibility of fully remote working across the UK, you will play a pivotal role in oncology programmes while engaging directly with sponsors and cross-functional teams. This is an excellent opportunity for those seeking meaningful work in a supportive environment that prioritises scientific accuracy and stakeholder management.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in CROs or have experience in regulatory writing. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Show off your expertise! When you get the chance to meet potential employers, whether at networking events or interviews, be ready to discuss your past projects and how you've tackled complex regulatory documents. Confidence is key!
✨Tip Number 3
Tailor your approach! Each company has its own vibe, so do a bit of research on their culture and values. When you apply through our website, make sure your application reflects how you align with their mission and how you can contribute to their oncology programmes.
✨Tip Number 4
Follow up! After an interview or networking event, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role. Plus, it’s a great way to reinforce your interest in working with them!
We think you need these skills to ace Senior Regulatory Medical Writer
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, and any relevant projects you've managed.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're the perfect fit for this role. Share your passion for regulatory writing and how your background aligns with our needs, particularly in managing complex documentation and stakeholder coordination.
Showcase Your Experience:When detailing your experience, focus on your achievements in regulatory writing. Mention specific documents you've prepared and any successful submissions you've been part of, especially in fast-paced environments.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. This way, we can easily track your application and get back to you quicker!
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 prepared to discuss specific documents like Clinical Study Protocols and IND applications, as well as any experience you have with Fast Track Applications. This will show that you’re not just familiar with the basics but can dive deep into the specifics.
✨Showcase Your Project Management Skills
Since this role involves managing multiple projects and coordinating with various stakeholders, be ready to share examples of how you've successfully juggled similar responsibilities in the past. Highlight your organisational skills and how you’ve ensured timelines are met while maintaining high-quality documentation.
✨Communicate Clearly and Confidently
Strong written communication is key for this position. During the interview, practice articulating your thoughts clearly and confidently. You might even want to prepare a brief overview of a past project where you had to manage stakeholder feedback and document revisions, showcasing your ability to communicate effectively.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to regulatory submissions or stakeholder management. Think about how you would handle tight deadlines or conflicting feedback from sponsors. This will demonstrate your strategic thinking and problem-solving abilities, which are crucial for this role.
