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- Tasks: Drive IND submissions and health authority interactions for exciting biotech projects.
- Company: Small biotech firm focused on innovative oncology solutions.
- Benefits: Flexible contract, competitive pay, and the chance to shape regulatory strategies.
- Why this job: Make a real impact in drug development and accelerate patient access to therapies.
- Qualifications: Experience in oncology and strong regulatory submission skills required.
- Other info: Collaborative environment with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Writing Consultant | 50-80% FTE 6 month contract
A small biotech is seeking an experienced, independent Regulatory Writer with strong Regulatory oversight to drive their near-term IND submission and health authority interactions across the US/EU/UK. You’ll partner with their Regulatory Consultant and CRO to plan, author, and QC key dossiers and amendments supporting ongoing Phase II studies, with an eye toward accelerated pathways and Phase III/registration readiness.
Role:
– Author IND and submit by EOY, with EU and UK documentation being completed in Q1 2026
– Own authoring/QC of eCTD documentation: protocol & IB amendments, CTAs, PIPs, iPSPs, CSR’s, MAA components, and briefing packages
– Provide regulatory strategy input (US/EU/UK) that shapes development plans (fast track / BTD), leveraging FDA agency experience
Experience required:
– Oncology development experience (immuno-oncology/immunology strongly preferred)
– Strong FDA experience, IND authoring/submission and familiarity with expedited regulatory pathways
– Proven regulatory submission experience across US/EU/UK for PHIII / registration (MAA/BLA)
– Hands-on authorship of IND’s, PIP’s, iPSP’s, CTA’s, MAA’s, CSR’s, IB & protocol amendments
– Strong writing and regulatory affairs experience, able to review/author sections with minimal oversight keeping within tight timelines
– Experience with eCTD structure and publisher-friendly drafting.
Regulatory Writer employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and regulatory writing fields. Attend industry events or webinars, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of IND submissions and regulatory pathways. We recommend creating a cheat sheet of key terms and processes to help you articulate your experience confidently. Practice makes perfect, so consider mock interviews with friends or colleagues.
✨Tip Number 3
Showcase your expertise! When you get the chance to chat with potential employers, highlight your hands-on experience with eCTD documentation and regulatory submissions. We want them to see you as the go-to person for their IND and MAA needs.
✨Tip Number 4
Don’t forget to apply through our website! It’s a great way to ensure your application gets noticed. Plus, we’re always looking for talented individuals like you to join our team and make an impact in the regulatory writing space.
We think you need these skills to ace Regulatory Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Writer role. Highlight your oncology development experience and any relevant regulatory submissions you've handled. We want to see how your skills align with our needs!
Showcase Your Writing Skills: Since this role is all about writing, include examples of your previous work if possible. Whether it’s INDs or eCTD documentation, we love seeing your ability to communicate complex information clearly and concisely.
Be Clear and Concise: When filling out your application, keep it straightforward. Use bullet points where you can and avoid jargon unless it's necessary. We appreciate clarity just as much as you do in regulatory documents!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Barrington James
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of IND submissions and the regulatory landscape in the US, EU, and UK. Familiarise yourself with expedited pathways and be ready to discuss how your experience aligns with the requirements of the role.
✨Showcase Your Writing Skills
Prepare samples of your previous regulatory documents, like protocols or CSR’s, to demonstrate your writing prowess. Be ready to explain your thought process behind authoring these documents and how you ensure compliance with regulatory standards.
✨Understand the Company’s Needs
Research the biotech company and their current projects, especially in oncology. Knowing their pipeline and how your role as a Regulatory Writer fits into their goals will show that you’re genuinely interested and invested in their success.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific regulatory challenges or tight deadlines. Think of examples from your past experiences where you successfully navigated similar situations, and be ready to share those stories.
