Remote Senior Country Regulatory Specialist, Clinical Research

7050 INC Research Clinical Services Mexico Limited, S.A. de C.V.; México; Remote; MXN 600,000 - 800,000; Full time

Job summary

Syneos Health in Mexico is seeking a Sr. Country Regulatory Specialist, Clinical Research, with 5–6 years in clinical research to lead country-level regulatory submissions from startup through project end. This role requires advanced English and strong liaison with RA/EC bodies in a 100% remote setup.

The ideal candidate will maintain regulatory intelligence, coordinate with cross-functional teams, and ensure compliance with local regulations and SOPs throughout the trial lifecycle.

Qualifications

• BA/BS preferred; 5–6 years in clinical research.
• In-depth understanding of RA/EC processes and timelines.
• Experience with per-country regulatory submissions.
• Strong communication and problem-solving skills.

Responsibilities

• Perform country regulatory operations from startup to project end.
• Serve as main country-level contact with RA and ECs.
• Maintain regulatory intelligence in regulatory intelligence systems.
• Prepare and submit Central/Local EC, RA applications and other submissions.
• Monitor timelines, budgets, and quality; escalate risks as needed.
• Provide SME guidance to project teams and junior staff.

Skills

Regulatory submissions

GxP knowledge

Project coordination

Stakeholder communication

RA/EC familiarity

Education

BA/BS in life sciences or related field

Tools

Microsoft Office

Regulatory databases

Job description

Syneos Health in Mexico is seeking a Sr. Country Regulatory Specialist, Clinical Research, with 5–6 years in clinical research to lead country-level regulatory submissions from startup through project end. This role requires advanced English and strong liaison with RA/EC bodies in a 100% remote setup.

The ideal candidate will maintain regulatory intelligence, coordinate with cross-functional teams, and ensure compliance with local regulations and SOPs throughout the trial lifecycle.