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- Tasks: Drive IND submissions and health authority interactions across US/EU/UK.
- Company: Small biotech 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 oncology development and accelerate drug approvals.
- Qualifications: Experience in regulatory writing and oncology development required.
- Other info: Join a dynamic team 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 introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Showcase your expertise! Create a portfolio that highlights your best work in regulatory writing. Include samples of IND submissions, eCTD documentation, and any other relevant projects. This will give potential employers a taste of what you can bring to the table.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of regulatory pathways and recent changes in the industry. Be ready to discuss your experience with FDA submissions and how you've navigated complex regulatory environments. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for talented regulatory writers like you. Keep an eye on our listings and make sure your application stands out by tailoring it to each role.
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 in regulatory writing. If you’ve authored INDs or other key documents, mention them! We love seeing your ability to communicate complex information clearly.
Be Specific About Your Experience: When detailing your experience, be specific about your familiarity with FDA processes and expedited regulatory pathways. We’re looking for someone who can hit the ground running, so let us know how you can contribute from day one!
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. Plus, it shows you’re keen on joining our team!
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 CSRs, 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. Knowing their focus areas, especially in oncology development, will help you tailor your responses and show that you’re genuinely interested in contributing to their goals.
✨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.
