Global Clinical Start-Up Specialist

Fortrea; Ciudad de México; Sur place; MXN 300 000 - 420 000; Plein temps

Résumé du poste

Fortrea is seeking an experienced regulatory start-up professional to serve as a local expert for site activation and maintenance across countries. You will collect, review, and prepare essential documents for regulatory submissions and ensure timelines align with project management and client expectations.

You will guide new hires, liaise with EC/IRB/Regulatory Authorities, and help maintain high-quality documentation to ensure audit-readiness for studies in the region.

Qualifications

• University/College degree in life science or related field with knowledge of regulatory guidelines.
• 2 years' work experience in clinical research and familiarity with RA/IRB/IEC regulations.

Responsabilités

• Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
• Coordinate, collect and organize data required by authorities for country applications and sponsor review.
• Prepare submissions and liaise with IRB/IEC/Regulatory Authorities on approvals.
• Collaborate with internal/external vendors for regulatory submissions.
• Ensure start-up and maintenance activities comply with laws, ICH/GCP, SOPs.

Connaissances

Regulatory knowledge

ICH guidelines

IRB/IEC regulations

Formation

Life science degree

Alternative with 2 years clinical research

Outils

CTIS

Regulatory submissions systems

Description du poste

Fortrea is seeking an experienced regulatory start-up professional to serve as a local expert for site activation and maintenance across countries. You will collect, review, and prepare essential documents for regulatory submissions and ensure timelines align with project management and client expectations.

You will guide new hires, liaise with EC/IRB/Regulatory Authorities, and help maintain high-quality documentation to ensure audit-readiness for studies in the region.