Regulatory Affairs Submissions Consultant
Regulatory Affairs Consultant Opportunity - EU/UK Submissions Specialist 📢
We are currently looking for an experienced Regulatory Affairs consultant / freelancer to support ad hoc regulatory submission activities on a fully remote basis.
This is an excellent opportunity for a hands-on RA professional with strong operational submission experience across UK and EU lifecycle management activities.
Key experience required:
✅ Regulatory variations experience (post-approval lifecycle management)
✅ Hands-on experience with electronic submission publishing (eCTD package preparation / compilation)
✅ Practical submission experience via MHRA submissions portal
✅ Experience with EMA / EU electronic submission processes and portals
✅ Strong understanding of regulatory dossier structure and submission requirements
✅ Ability to work independently with minimal supervision
✅ Excellent attention to detail and accuracy when preparing and reviewing submission documents
✅ Strong organisational and time-management skills, with the ability to handle multiple submissions concurrently
✅ Effective communication skills for cross-functional collaboration with regulatory, clinical, and quality teams
Role details:
📍 Fully remote
📍 Ad hoc / flexible consulting support
📍 Outside IR35 (UK)
📍 Immediate / near-term requirement
This is a practical delivery-focused role, so we are looking for someone who can actively prepare, publish and submit dossiers-not purely strategy-focused profiles.
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