Manager, Global Regulatory Science CTA
Core
Lead global Clinical Trial Application (CTA) operations outside the US and serve as the subject matter expert for the UK regulatory landscape to enable timely advancement of mRNA medicines.
Role type
Manager, Global Regulatory Science CTA
Builds
Global clinical trial submission packages and operational plans for mRNA medicines
Domain
Biopharma / mRNA therapeutics / Clinical Trials
Deliverable
client delivery
Required skills
Regulatory CTA submission expertise, EU Regulation 536/2014 knowledge, UK CTAs/IRAS experience, CRO management, regulatory platform administration (CTIS, IRAS, Veeva RIM), cross-functional collaboration, strategic regulatory guidance
Preferred skills
Experience with emerging UK clinical trials legislation, AI-enabled tools for regulatory operations
Technologies
CTIS, IRAS, Veeva RIM
Responsibilities
Lead global CTA activities outside the US IND framework, coordinate CROs for high-quality deliverables, prepare and execute CTA submission packages, manage sponsor-side administration in regulatory platforms, oversee regulatory query management, maintain inspection-ready documentation, provide strategic guidance on MHRA expectations and UK regulations, monitor adherence to global CTA processes
Seniority
Manager, operational leadership & strategic expertise