Regulatory & Site Activation Expert

Worldwide; Buenos Aires; Hybrid; ARS 89,322,000 - 148,869,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory submissions

Site start-up

Regulatory intelligence

Communication skills

MS Office

Education

Science degree

Biology/Pharmacy background

Tools

Regulatory databases

Job description

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.