Remote Senior Regulatory & Start-Up Specialist - Argentina

Precision Medicine Group; Argentina; A distancia; ARS 1.800.000 - 2.600.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist (Argentina) to drive regulatory submissions, site activation, and EC/IRB coordination across the country. The role involves collaboration with CA, EC, and site teams to ensure timely approvals and compliant start-up activities.

The ideal candidate has a life sciences background, 3.5+ years in regulatory/start-up roles, and excellent English communication.

Formación

• Bachelor’s degree in life sciences or RN or related field is required.
• 3.5+ years as Regulatory or Site Start-Up specialist in CRO or pharmaceutical/biotech is preferred.
• Fluency in English (professional level) is required.

Responsabilidades

• Deliver site activation readiness within assigned country/sites on time and with quality.
• Prepare Clinical Trial Application Forms and submission dossiers for CA/EC within timelines.
• Interact with Competent Authorities and Ethics Committees; respond to inquiries and maintain filings.
• Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Lead and Project Manager.
• Partner with site CRA to ensure alignment and secure site collaboration.
• Translate and coordinate translations for submission documents when needed.

Conocimientos

Excellent communication

Organizational skills

Fluency in English

Educación

Bachelor’s degree in life sciences or RN or related

Advanced degree in medical or life sciences (MD, PhD, PharmD) / RAC

Descripción del empleo

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist (Argentina) to drive regulatory submissions, site activation, and EC/IRB coordination across the country. The role involves collaboration with CA, EC, and site teams to ensure timely approvals and compliant start-up activities.

The ideal candidate has a life sciences background, 3.5+ years in regulatory/start-up roles, and excellent English communication.