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:
âś… Regulatory variations experience (post-approval lifecycle management)
âś… Hands-on experience with electronic submission publishing (eCTD package preparation / compilation)
âś… Practical submission experience via MHRA submissions portal
âś… Experience with EMA / EU electronic submission processes and portals
âś… Strong understanding of regulatory dossier structure and submission requirements
âś… Ability to work independently with minimal supervision
âś… Excellent attention to detail and accuracy when preparing and reviewing submission documents
âś… Strong organisational and time-management skills, with the ability to handle multiple submissions concurrently
âś… Effective communication skills for cross-functional collaboration with regulatory, clinical, and quality teams
Role details:
đź“Ť Fully remote
đź“Ť Ad hoc / flexible consulting support
đź“Ť Outside IR35 (UK)
đź“Ť 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.