Senior Regulatory and Start Up Specialist (Mexico) (Fully Remote)

Precision Medicine Group (New York, United States); United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Precision Medicine Group in New York seeks an experienced regulatory start-up specialist to drive the submission of clinical trial applications to regulatory authorities and ethics committees. You will manage essential documents, informed consent forms, and site activation readiness to mitigate timeline risks.

You will serve as a subject-matter expert and mentor for site start-up activities, maintaining regulatory intelligence and ensuring audit readiness across trials.

Responsibilities

• Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees.
• Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
• Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.

Job description

• - Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
• - Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
• - Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.