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) (Xico)
🏢 Worldwide Clinical Trials
📍 Xico