Regulatory Affairs Consultant EU and US

Your new company A leading Regulatory Affairs consultancy looking for an experienced regulatory professional to support one of the Regulatory Strategy Leads across EU and US development activities. The role requires a hands-on individual with a strong clinical regulatory background, operational submission experience, and working knowledge of both EMA centralised procedures and FDA regulatory requirements.This is a remote, outside IR35 contract job in Regulatory Affairs. Your new role Regulatory Operational SupportProvide operational regulatory support to the assigned Regulatory Strategy Lead.Support EU and US development regulatory activities across ongoing programmes.Coordinate regulatory timelines, deliverables, and submission readiness activities.Track and manage regulatory actions, commitments, and submission milestones.Support internal governance and cross-functional coordination activities.Clinical Regulatory DocumentationPerform hands-on preparation, review, formatting, and maintenance of regulatory documentation.Support updates to clinical and regulatory documents in line with authority expectations.Coordinate document version control and ensure submission-ready quality standards.Support authoring coordination activities across internal stakeholders and external vendors where applicable.EU Centralised Procedure SupportProvide operational support for EMA centralised procedure activities.Assist with dossier compilation and submission coordination.Support life cycle ..... full job details .....