Barrington James
Senior Regulatory Affairs Consultant
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Freelance Senior Regulatory Affairs Consultant | 12-Month Contract | Remote (Europe)
About The Opportunity
A rapidly growing late-stage biotechnology company is seeking an experienced Senior Regulatory Affairs Consultant to support its expanding global development portfolio as it prepares for major regulatory submissions and commercialisation activities.
With a lead biologic entering a critical regulatory phase following positive Phase 3 data, this consultant will play a key role in driving global regulatory strategy, coordinating major submissions, and supporting interactions with international health authorities.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
Key Responsibilities
- Lead regulatory strategy for late-stage biologics programmes across the US and Europe.
- Support preparation and execution of BLA, MAA, and other global marketing applications.
- Coordinate regulatory activities across Clinical Development, CMC, Quality, Pharmacovigilance, and Medical Writing.
- Prepare briefing documents for FDA, EMA, and other global health authority interactions.
- Provide strategic input into lifecycle management and indication expansion plans.
- Review CTD documentation and ensure submission readiness.
- Assess regulatory risks and recommend mitigation strategies.
- Support responses to health authority questions throughout the review process.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
What we are looking for
- 8+ years' experience within Regulatory Affairs in biotech, pharmaceutical, or consultancy environments.
- Demonstrated experience supporting late-stage biologics development.
- Experience preparing or leading BLA, MAA, or major global submissions.
- Strong knowledge of FDA, EMA, and ICH regulatory requirements.
- Previous experience supporting health authority meetings and regulatory negotiations.
- Excellent stakeholder management and project leadership skills.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills
Location