Regulatory & Site Activation Expert

Worldwide; Buenos Aires; Híbrido; ARS 89.322.000 - 148.869.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials in Argentina seeks a subject matter expert and local point of contact for regulatory submissions, site activation, and maintenance for awarded projects. You will plan, initiate, and track documents required for regulatory submissions, and ensure country requirements are met to achieve site activation goals.

You will coordinate with RAM and project teams, review country timelines, communicate risks, and maintain regulatory intelligence.

Formación

• Minimum 2-year college curriculum in medical, biological, physical, health, pharmacy or related science.
• Minimum 2 years of experience in clinical research, preferably in site activation/regulatory function.
• Multilingual; fluent in local language with working knowledge of English.

Responsabilidades

• Support end-to-end site start-up from site identification to activation and maintenance as primary country contact.
• Act as country-level regulatory and site activation lead for assigned studies.
• Customize country-specific regulatory documents to comply with ICH GCP and local regulations.

Conocimientos

Regulatory submissions

Site start-up

Regulatory intelligence

Communication skills

MS Office

Educación

Science degree

Biology/Pharmacy background

Herramientas

Regulatory databases

Descripción del empleo

Worldwide Clinical Trials in Argentina seeks a subject matter expert and local point of contact for regulatory submissions, site activation, and maintenance for awarded projects. You will plan, initiate, and track documents required for regulatory submissions, and ensure country requirements are met to achieve site activation goals.

You will coordinate with RAM and project teams, review country timelines, communicate risks, and maintain regulatory intelligence.