About the Role
The position focuses on managing regulatory documentation and enabling rapid site activation for clinical studies within Mexico and potentially broader Latin American regions, ensuring adherence to local and international regulations.
Responsibilities
- Prepare and submit regulatory documents to national health authorities in Mexico
- Coordinate the activation of clinical trial sites across designated regions
- Ensure all regulatory requirements are met for each study location
- Maintain up-to-date knowledge of local regulatory guidelines and changes
- Support the development of essential regulatory plans for trial initiation
- Liaise with internal teams to collect required documentation for submissions
- Track and manage submission timelines and approval processes
- Verify accuracy and completeness of regulatory packages
- Manage relationships with local ethics committees and regulatory bodies
- Assist in the translation and validation of documents as needed
- Maintain regulatory databases with current site and submission information
- Ensure compliance with company procedures and international standards
- Participate in audits and inspections related to regulatory processes
- Support cross-functional teams during study start-up phases
- Provide input on country-specific regulatory strategies
- Monitor regulatory performance metrics and report findings
- Escalate potential risks or delays in site activation
- Ensure proper archiving of regulatory records
- Collaborate with legal and compliance departments when necessary
- Assist in training regional staff on regulatory processes
Nice to Have
- Experience working with multinational clinical trial teams
- Prior work in a CRO environment
- Knowledge of eRegulatory platforms
- Certification in clinical research or regulatory affairs
- Experience supporting trials in Latin America
Compensation
Not specified
Work Arrangement
Remote
Team
Global clinical operations team
Why Join Us
- Opportunity to contribute to global clinical research initiatives from a remote location
- Work within a supportive, international team committed to patient impact
- Access to professional development and growth opportunities
- Be part of a company that values regulatory excellence and operational efficiency
What You’ll Achieve
- Accelerate clinical trial timelines through efficient site activation
- Ensure regulatory compliance across diverse jurisdictions
- Support faster access to treatments by streamlining startup processes
- Contribute to high-quality submissions with minimal resubmissions
Not offered
