Local Strategic Regulatory Specialist (Xoco)

Site Name: Mexico City Torre Mitikah

Posted Date: Dec

The Local Regulatory Specialist is responsible for providing and support in the set-up and execution of the regulatory strategy for all clinical trials, across all therapeutic areas to achieve the Study Start‑up process. This includes, but it’s not limited to, the oversight of the following processes: submission of the Country Core Package Complete to the Ethics, Research and Biosafety Committees, preparation and submission of the Initial Clinical Trial Application to the Local Regulatory Authority and support ongoing activities during site maintenance and close‑out.

• Responsible for setting up the appropriate submissions’ strategy for the study in collaboration with the local study team, providing insights to the study team to ensure the best possible outcome for regulatory and/or ethics committee submissions.
• Work closely with the local...