Senior Regulatory Affairs Associate, CTA Senior Specialist

About the role

A remote senior role supporting clinical trial authorization submissions and regulatory compliance. The specialist shapes CTA strategy, executes submissions and keeps global filings compliant so new treatments reach patients.

What you will do

• Prepare and coordinate global CTA and amendment documents, ensuring dossiers are complete and high quality
• Manage or facilitate filings with health authorities and act as the main contact for regulatory exchanges
• Oversee contract research organisations handling submissions and queries, ensuring timely accurate replies
• Apply global CTA strategy and confirm compliance with each country's specific requirements
• Track and archive regulatory submissions and share EU requirements and updates with cross-functional teams

What they look for

• Demonstrated leadership in EU CTA documentation and submissions
• A track record of managing complex regulatory processes successfully
• Strong knowledge of regulatory affairs and clinical trial application work