Remote Country Regulatory Specialist, Clinical Research

Syneos Health, Inc.; México; Remote; MXN 420,000 - 640,000; Full time

Job summary

Syneos Health, Inc. is seeking a Sr Country Regulatory Specialist to lead regulatory operations remotely from Mexico, covering country-level submissions from startup to project end. You will collaborate with RA, ECs, and cross-functional teams to ensure compliance and timely delivery.

The role requires 5–6 years in clinical research or regulatory roles, strong knowledge of ICH GCP and country regulations, and excellent communication skills to influence projects across global teams.

Qualifications

• BA/BS degree or higher preferred.
• 5-6 years in Clinical Research or regulatory roles.
• Solid knowledge of country-level RA/EC processes.

Responsibilities

• Provide country regulatory operations and submissions from startup to project end.
• Serve as main country-level contact with regulatory authorities and ethics committees.
• Maintain country regulatory intelligence in regulatory systems.
• Interact with customers regarding regulatory requirements.
• Prepare regulatory submissions and amendments as required.
• Mentor junior regulatory specialists when needed.
• Ensure TMF documentation complies with SOPs and client requirements.
• Monitor workload, budgeted effort, and project hours.

Skills

Regulatory submissions

GxP compliance

Cross-functional collaboration

Project management

ICH GCP knowledge

Communication skills

Regulatory intelligence

QA/document control

Education

BA/BS degree

Job description

Syneos Health, Inc. is seeking a Sr Country Regulatory Specialist to lead regulatory operations remotely from Mexico, covering country-level submissions from startup to project end. You will collaborate with RA, ECs, and cross-functional teams to ensure compliance and timely delivery.

The role requires 5–6 years in clinical research or regulatory roles, strong knowledge of ICH GCP and country regulations, and excellent communication skills to influence projects across global teams.