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 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, commitments, and submission milestones.
• Support internal governance and cross-functional coordination activities.

Clinical Regulatory Documentation

• Perform 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 Support

• Provide operational support for EMA centralised procedure activities.
• Assist with dossier compilation 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 Support

• Support US regulatory operational activities and FDA-related documentation requirements.
• Assist with submission preparation and document management activities for US filings.
• Coordinate responses, updates, and submission components in collaboration with the Regulatory Strategy Lead.

What you'll need to succeed

What you'll get in return
Remote working, outside IR35 rate

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.