Senior Regulatory & Start-Up Specialist - Remote (Mexico)

Precision for Medicine; Ciudad de México; Hybrid; MXN 1,000,000 - 1,800,000; Full time

Job summary

Precision Medicine Group in Mexico is seeking a Senior Regulatory and Start Up Specialist to lead country-specific regulatory and site start-up activities for clinical trials. You will manage CTAs, submissions to CA/EC, ICF reviews, essential document handling, and coordination with the Site Contracts team.

The role requires deep regulatory experience in Mexico, strong English communication, and the ability to mentor in-country staff while ensuring compliance with ICH-GCP and local regulations.

Qualifications

• Bachelor's degree in life sciences or RN or equivalent combination of education, training, and experience
• 3.5 years or more as a Regulatory or SU specialist in CRO/pharma/biotech setting
• English proficiency at a professional level (written and spoken)

Responsibilities

• Ensure site activation readiness within assigned country/sites with on-time delivery and risk mitigation
• Prepare Clinical Trial Applications and submission dossiers for CA/EC and local bodies
• Interact with CA/EC and respond to inquiries during study purposes
• Provide regular updates to Start Up Lead/Regulatory Lead and Project Manager
• Maintain project plans and regulatory trackers and stay informed on regulatory intelligence

Skills

Communication skills

English proficiency

Organizational skills

Attention to detail

Time management

Education

Bachelor's degree in life sciences

Advanced degree in medical or life sciences

Tools

Spreadsheets

Word processing

Email

Job description

Precision Medicine Group in Mexico is seeking a Senior Regulatory and Start Up Specialist to lead country-specific regulatory and site start-up activities for clinical trials. You will manage CTAs, submissions to CA/EC, ICF reviews, essential document handling, and coordination with the Site Contracts team.

The role requires deep regulatory experience in Mexico, strong English communication, and the ability to mentor in-country staff while ensuring compliance with ICH-GCP and local regulations.