Remote Regulatory Specialist – Clinical Research (Mexico)

Syneos Health Careers; México; Remote; MXN 600,000 - 800,000; Full time

Job summary

Syneos Health is seeking a Sr Country Regulatory Specialist, Clinical Research, 100% remote in Mexico. You will lead country-level regulatory submissions, interact with authorities, and ensure on-time delivery across startup to project end, within GxP guidelines.

The role requires advanced English, 5–6 years in clinical research, strong knowledge of RA/EC processes, and the ability to mentor junior staff while maintaining regulatory intelligence and TMF compliance.

Qualifications

• Minimum of a BA or BS preferred.
• 5-6 years minimum experience in Clinical Research or equivalent.
• Detailed understanding of clinical trial processes across Phases I-IV and ICH GCP.
• Experience with country regulatory submissions and local regulations.

Responsibilities

• Perform country regulatory operations and ensure timely submissions.
• Serve as main country-level contact with Regulatory Authorities and Ethics Committees.
• Maintain regulatory country intelligence and TMF compliance.
• Provide SME knowledge during pre-award and site-selection stages.

Skills

Regulatory knowledge

Project coordination

Communication skills

MS Office

GxP knowledge

Education

BA or BS degree

Tools

Microsoft Office Suite

Job description

Syneos Health is seeking a Sr Country Regulatory Specialist, Clinical Research, 100% remote in Mexico. You will lead country-level regulatory submissions, interact with authorities, and ensure on-time delivery across startup to project end, within GxP guidelines.

The role requires advanced English, 5–6 years in clinical research, strong knowledge of RA/EC processes, and the ability to mentor junior staff while maintaining regulatory intelligence and TMF compliance.