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Job description
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.
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 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 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 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 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
