Global Regulatory & Site Activation Specialist

Worldwide Clinical Trials; Ciudad de México; Presencial; MXN 420.000 - 620.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials seeks a regulatory start-up professional to manage end‑to‑end site activation for awarded projects. You will coordinate regulatory submissions, essential document collection, and country‑specific requirements to support timely site initiation.

Responsibilities include local liaison for regulatory activities, customization of country documents, risk assessment, and proactive communication with RAM and project teams to ensure milestones are met with quality and compliance.

Formación

• A minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science.
• Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory-related function.
• Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations.
• Multilingualism preferred; fluent in local language; working knowledge of English.

Responsabilidades

• Support end-to-end site start-up from site identification to site activation and maintenance as the primary contact for the site.
• Act as country-level regulatory and site activation advisor for assigned studies.
• Review and adapt country-specific regulatory documents to comply with ICH GCP and local requirements.
• Communicate timelines, risks, and actions to RAM and project team; track regulatory documents by site/country.

Conocimientos

Regulatory submissions

Site startup

Regulatory strategy

Documentation review

MS Office

Educación

Associate degree in life sciences

Herramientas

MS Office Suite

Descripción del empleo

Worldwide Clinical Trials seeks a regulatory start-up professional to manage end‑to‑end site activation for awarded projects. You will coordinate regulatory submissions, essential document collection, and country‑specific requirements to support timely site initiation.

Responsibilities include local liaison for regulatory activities, customization of country documents, risk assessment, and proactive communication with RAM and project teams to ensure milestones are met with quality and compliance.