regulatory and site activation specialist serving as the local expert and primary contact for clinical trial submissions and site start-up activities in mexico. The role involves managing regulatory documentation, coordinating with sites, ensuring compliance with local requirements, and supporting project teams throughout trial initiation and maintenance phases.

responsibilities

- serve as primary contact for end-to-end site start-up, from identification through activation and ongoing maintenance
- develop country-specific regulatory documents including patient information sheets, informed consent forms, and labels compliant with ich gcp and local requirements
- collect, review, and track study-specific regulatory and essential documents by site and country
- communicate status, risks, and mitigation strategies to the regulatory affairs manager and project team members




- maintain regular communication with sites, identify regulatory risks proactively, and provide updates on changing local requirements

requirements

- minimum 2 years clinical research experience, preferably in site activation or regulatory functions
- associate degree or higher in medical, biological, health, pharmacy, or related science
- strong knowledge of ich gcp, clinical research guidance, and country-specific regulations
- fluency in spanish or local language; working proficiency in english
- excellent organizational, planning, and written/verbal communication skills
- proficiency in microsoft office applications (word, excel, powerpoint)
- preferred: one year pharmaceutical or cro industry experience

📌 Specialist, regulatory and site activation ( mexico) (Ciudad de México)
🏢 Worldwide Clinical Trials
📍 Ciudad de México