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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