Regulatory & Start Up Specialist 2, cFSP

Location: Full home-based role in Mexico City, Mexico

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Support end-to-end site management from feasibility and qualification through regulatory activation, maintenance, and close-out.
• Act as the primary contact for assigned investigative sites, countries, and study team members.
• Participate in study team meetings and provide detailed updates on study and site activities.
• Track assigned activities, prepare reports and metrics, and manage essential document collection, review, and tracking.
• Support country and site intelligence gathering, Ethics Committee and Regulatory Authority submissions, and site-specific activation activities.
• Coordinate activities such as import/export licenses, radiation board approvals, and biobank committee approvals when required.

Requirements

• Bachelor’s degree in Life Science, Business Administration, Finance, or a related field, or equivalent work experience.
• At least three years of relevant experience in the biopharmaceutical or CRO industry, including Ethics Committee submission experience in Mexico.
• Experience customizing informed consent forms (ICFs).
• Fluent English in written and oral communication.
• Proficiency with Veeva Vault and Microsoft Office applications.
• Ability to negotiate complex contract and payment terms, manage multiple deliverables, identify issues, and work independently.

Culture & Benefits

• Full home-based work arrangement.
• Opportunity to support clinical studies and the development of medical treatments.
• Work across regulatory, operational, and cross-functional study activities.