Country Approval Specialist / Sr Country Approval Specialist
RemoteMexico or Argentina
Job Summary
Site Activation & Country Approval Specialist (Sr.) drives efficient start-up of clinical studies by coordinating site activation and regulatory submission activities, preparing regulatory documents for local authorities and ethics committees, developing country-specific approaches, and ensuring compliance with ICH-GCP and SOPs. Collaborates with investigators, sponsors, and internal teams to manage submissions, site agreements, budgets, essential documents, and activation milestones, while mentoring colleagues when applicable. The role emphasizes regulatory submissions, country-level approvals, site activation strategies, and cross-functional coordination across global teams in a remote/office-based environment.
Required Qualifications
- Bachelor’s degree in Life Sciences, Healthcare, Regulatory Affairs, or a related field, or an equivalent combination of education and experience
- Strong understanding of clinical research processes and site start-up activities
- Experience in regulatory submissions, clinical operations, or related areas within pharmaceutical, biotechnology, CRO, or healthcare environment
- Proficiency with Microsoft Office and clinical trial management systems
- English proficiency required
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