Regulatory Submissions Coordinator (Study Start Up)

Overview

In this Regulatory Submissions Coordinator role, you will support the clinical trial lifecycle by preparing and submitting regulatory documents to UK authorities and Ethics Committees. You’ll work with the Clinical Operations team to ensure compliance and timely filing, maintaining essential documentation and the Clinical Trial Management System. You’ll influence regulatory strategy by advising on changing guidelines and coordinating responses. This is an office-based position in London with opportunities to grow your regulatory expertise within a global CRO.

Pay / Benefits

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Responsibilities

• Prepare, review, and file initial clinical trial applications to regulatory authorities
• Submit responses to queries and amendments for regulatory applications
• Ensure submissions comply with applicable regulations and guidance
• Advise team on changing regulations and compliance requirements
• Maintain the Clinical Trial Management System and ensure timely filing of documents
• Collect essential documents and prepare packages for drug release

Key requirements

• Bachelor’s degree, preferably Life Sciences
• Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies (including responses to queries)
• Relevant working experience at a CRO, pharmaceutical company, or investigative site
• Knowledge of UK regulatory guidelines
• Excellent organizational and prioritization skills
• Ability to work independently with a proactive approach
• Knowledge of Microsoft Office
• Strong attention to detail and oral/written communication skills

• Excellent organizational skills
• Strong prioritization and time-management
• Independent and proactive work style
• Microsoft Office
• Knowledge of regulatory guidelines in the UK
• Experience with Clinical Trial Management System

…