Senior Regulatory & Start-Up Lead – Mexico

pfm; México; On-site; MXN 600,000 - 900,000; Full time

Job summary

Precision for Medicine in Mexico is seeking a Senior Regulatory and Start Up Specialist to lead site activation and regulatory submissions across assigned countries. You will ensure timely readiness of trial activations, prepare regulatory submissions to authorities and IRBs, review essential documents, and collaborate with sites and cross-functional teams.

As SME for country start-up activities, you will mentor staff, manage regulatory intelligence, and support budget negotiation with site

Qualifications

• Minimum Required: Bachelor's degree in life sciences or related field (ideally in a scientific or healthcare discipline).

Responsibilities

• Delivery of site activation readiness within the assigned country/sites, ensuring timeliness and quality.
• Prepare Clinical Trial Application Forms and submission dossiers for CA/EC within local timelines.
• Interact with CA/EC and handle study responses; provide updates to Start Up Lead/Regulatory Lead and Project Manager.
• Maintain project plans, trackers and regulatory intelligence tools; support country start-up plans and IMP release requirements.
• Partner with site CRA to ensure alignment and secure site collaboration; collect and manage essential activation/IMP documents.
• Translate and coordinate translations for submission documents; maintain communication with Feasibility, Clinical Operations, Regulatory, Site Contracts groups.
• Act as SME for country start-up data points (CA/EC timelines, site contracts, budgets); mentor staff on local regulations.
• Support training sessions to expand Country Start-up knowledge and assist with client proposals as needed.

Education

Bachelor's degree in life sciences or related field

Job description

Precision for Medicine in Mexico is seeking a Senior Regulatory and Start Up Specialist to lead site activation and regulatory submissions across assigned countries. You will ensure timely readiness of trial activations, prepare regulatory submissions to authorities and IRBs, review essential documents, and collaborate with sites and cross-functional teams.

As SME for country start-up activities, you will mentor staff, manage regulatory intelligence, and support budget negotiation with site