Senior Regulatory & Start-Up Specialist Argentina (Remote)

Precision Medicine Group; Argentina; A distancia; ARS 1.200.000 - 2.100.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist (Argentina), remote in Argentina. You will lead regulatory submissions, informed consent adaptations, essential document review, and support for site activation across the country according to local and international regulations.

The role includes acting as SME for country-specific tools, training staff, and coordinating with CA/EC, IRB/Ethics Committees, and Site Contracts management.

Formación

• Bachelor's degree in life sciences or RN or equivalent.
• 3.5+ years as Regulatory or Start-Up specialist in CRO/pharma environment.
• English proficiency at a professional level.

Responsabilidades

• Ensure site activation readiness in the assigned country/sites.
• Prepare Clinical Trial Applications and submission dossiers for CA/EC.
• Interact with CA/EC and respond to inquiries during submissions.
• Maintain regulatory trackers and TMF documents; support start-up processes.
• Provide SME guidance and training on country start-up activities.

Conocimientos

Regulatory & Start-Up expertise

Communication

Organizational skills

English proficiency

Educación

Bachelor's degree in life sciences or related field

Registered Nurse (RN) or equivalent

Descripción del empleo

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist (Argentina), remote in Argentina. You will lead regulatory submissions, informed consent adaptations, essential document review, and support for site activation across the country according to local and international regulations.

The role includes acting as SME for country-specific tools, training staff, and coordinating with CA/EC, IRB/Ethics Committees, and Site Contracts management.