Posted: 25 May
The role
Your newpany
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 Support
Provide 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,mitments, and submission milestones.Support internalernance 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 dossierpilation and submission coordination.Support life cycle management activities associated with development submissions.Ensure alignment of submission documentation with EU regulatory requirements and timelines.FDA Regulatory SupportSupport US regulatory operational activities and FDA-related documentation requirements.Assist with submission preparation and document management activities for US filings.Coordinate responses, updates, and submissionponents in collaboration with the Regulatory Strategy Lead.
What you'll need to succeed
What you'll get in return
Remote working, outside IR35 rate
