Senior Regulatory Specialist

Clinical Regulatory Operations Specialist

I'm currently supporting an our client for a long-term Clinical Regulatory Operations engagement for an experienced regulatory professional with strong hands-on clinical trial submission experience.

This is an operational role for someone who enjoys being directly involved in the execution of regulatory submissions across Europe, the UK and ROW.

Key responsibilities

• Manage Clinical Trial Application (CTA) submissions and amendments
• Support EU submissions through CTIS
• Manage UK submissions through IRAS
• Prepare and coordinate regulatory submission packages
• Review and approve content plans and submission documentation
• Coordinate with central and local regulatory/study teams
• Manage Health Authority RFIs / queries
• Maintain submission trackers, regulatory systems and documentation
• Support submission acknowledgements, approvals and archival
• Work with Veeva Vault and other regulatory systems

What we're looking for

• Proven hands-on Clinical Trial Regulatory / Regulatory Operations experience
• Strong experience with CTA submissions
• Practical experience with CTIS and/or IRAS
• Experience managing regulatory submissions from preparation through to approval
• RFI / Health Authority query management experience
• Veeva Vault experience highly desirable
• Experience working across EU, UK and/or ROW submissions
• Strong organisational and stakeholder-management skills
• Available to start ASAP

This is particularly well suited to Regulatory professionals from CRO or pharmaceutical environments who are comfortable being hands-on with submission execution rather than purely strategic Regulatory Affairs.

If you have strong clinical trial submission experience and are open to a long-term contract opportunity, please get in touch directly or message me for further details.

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