Remote Senior Regulatory & Start-Up Specialist - Mexico

Precision Medicine Group; México; Remote; MXN 1,200,000 - 1,700,000; Full time

Job summary

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist for Mexico. The role focuses on regulatory submissions, site activation, and ICH-GCP compliance across multiple countries in the region.

Remote work within Mexico is supported, with collaboration across in-country teams and external bodies. You will manage timelines, draft regulatory documents, and liaise with authorities and ethics committees to obtain necessary approvals for clinical trials.

Qualifications

• Regulatory and site start-up experience in CRO or pharma/biotech industries.
• Professional proficiency in English; local language for Mexico may be required.
• Ability to manage documentation, timelines and regulatory submissions.

Responsibilities

• Lead regulatory submissions and site activation for Mexican sites.
• Prepare Clinical Trial Applications and submission dossiers per CA/EC timelines.
• Coordinate with CA, EC, IRB/EC, and study teams on submissions and responses.
• Maintain project plans, trackers, and regulatory intelligence tools; mentor staff.

Skills

Regulatory expertise

Site start-up

English proficiency

Project coordination

Documentation management

Education

Bachelor's degree in life sciences

RN or equivalent

Job description

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist for Mexico. The role focuses on regulatory submissions, site activation, and ICH-GCP compliance across multiple countries in the region.

Remote work within Mexico is supported, with collaboration across in-country teams and external bodies. You will manage timelines, draft regulatory documents, and liaise with authorities and ethics committees to obtain necessary approvals for clinical trials.