Senior Regulatory Affairs Associate, CTA Senior Specialist

About the role

A remote role supporting clinical trial authorization submissions and compliance activities. The position helps advance new treatments by guiding CTA strategy, submissions and health authority interactions.

What you will do

• Support CTA submissions and maintenance work while keeping all activities compliant
• Prepare and coordinate global CTA and amendment documents, managing dossiers for quality and completeness
• Handle or facilitate health authority submissions and act as the main contact for regulatory interactions
• Oversee contract research organisations on submissions and queries so responses are timely and accurate
• Apply global CTA strategy and ensure country-specific requirements are met across submissions
• Track and archive submissions, share EU regulatory updates with cross-functional teams and improve processes

What they look for

• Demonstrated leadership in EU CTA documentation and submissions
• A track record of managing complex regulatory processes successfully