Senior Regulatory & Start-Up Specialist — Remote Argentina

Precision for Medicine; Argentina; Presencial; ARS 900.000 - 1.400.000; Jornada completa

Descripción de la vacante

Precision for Medicine is seeking a Senior Regulatory and Start Up Specialist (Argentina) to lead regulatory and site start-up activities in the region. The role involves preparing submissions to Competent Authorities and Ethics Committees, adapting Informed Consent Forms, and ensuring on-time approvals for clinical trials.

You will collaborate with CA/EC, site CRA, and cross-functional teams, maintaining TMF readiness and knowledge of local laws.

Formación

• Bachelor’s degree in life sciences or RN or equivalent.
• 3.5+ years as Regulatory or Start-Up specialist in CRO/pharma.
• Professional English communication.

Responsabilidades

• Deliver site activation readiness within assigned country/sites with attention to timeliness and quality.
• Prepare Clinical Trial Applications and submission dossiers for CA, EC, and local bodies.
• Interact with CA/EC for study purposes and handle responses.
• Provide updates on submissions to Start Up Lead/Regulatory Lead and Project Team.
• Maintain project plans, trackers, and regulatory intelligence tools.

Conocimientos

Regulatory knowledge

English proficiency

Educación

Bachelor's degree in life sciences or RN

Descripción del empleo

Precision for Medicine is seeking a Senior Regulatory and Start Up Specialist (Argentina) to lead regulatory and site start-up activities in the region. The role involves preparing submissions to Competent Authorities and Ethics Committees, adapting Informed Consent Forms, and ensuring on-time approvals for clinical trials.

You will collaborate with CA/EC, site CRA, and cross-functional teams, maintaining TMF readiness and knowledge of local laws.