Regulatory Affairs Consultant EU and US
Posted Today by Hays Life Sciences
£60 Per hour
Outside
Remote
Uxbridge, London
Summary: The role of Regulatory Affairs Consultant involves providing operational regulatory support to a Regulatory Strategy Lead for EU and US development activities. The position requires a strong clinical regulatory background and experience with submission processes for both EMA and FDA. This is a remote contract position classified as outside IR35. The consultant will be responsible for coordinating regulatory timelines, documentation, and compliance with regulatory requirements.
Key Responsibilities:
- 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.
- 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.
- 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.
- 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.
Key Skills:
- Strong clinical regulatory background.
- Operational submission experience.
- Knowledge of EMA centralised procedures.
- Understanding of FDA regulatory requirements.
- Experience in regulatory documentation preparation and management.
- Ability to coordinate cross-functional activities.
- Strong organizational and communication skills.
Salary (Rate): £60.00/hour
City: Uxbridge
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: Mid-Level
Industry: Other
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 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 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 rateWhat you need to do nowIf 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.