Experteer Overview
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In this role, you will manage local regulatory submissions and coordinate activities aligned with our integral submission strategy. You will act as the country-level regulatory contact, ensuring timely, compliant submissions and effective cross-functional collaboration to activate sites. You’ll support country-specific regulatory advice, SIA services, and study-related documentation to contribute to successful trials. This is an opportunity to shape regulatory execution across multiple countries within a global innovation-focused organization.
Compensaciones / Beneficios
• Prepare, review and coordinate local regulatory submissions (MoH, EC, and local applications) per global strategy
• Provide local regulatory strategy guidance to internal clients
• Coordinate project-specific local SIA services and activities
• Serve as key contact for country-level submission-related activities (Ethical or Regulatory)
• Coordinate with internal departments to align site start-up activities with submission timelines and critical paths




• Contribute to achieving target cycle times for site activation
• Assist with regulatory compliance review packages and country-specific Patient Information Sheets/Consent forms as applicable
• Support feasibility activities and manage trial status information in PPD tracking databases
• Ensure local country study files and filing follow PPD/Client SOPs and regulatory guidelines
• Maintain knowledge of PPD and Client SOPs and current regulatory guidelines
Responsabilidades
• Bachelor degree or equivalent and relevant experience
• 2+ years of experience or equivalent combination of education xqbhyrx and experience
• Strong written and verbal communication skills
• Good interpersonal and negotiation skills
• Attention to detail and documentation quality
• Proficiency with computers and relevant software
• Good English language and grammar skills
• Basic medical/therapeutic knowledge and regulatory guideline familiarity
• Ability to work in team or independently under direction
• Basic organizational and planning skills
• Knowledge of regional/national regulatory guidelines and EC regulations
Requisitos principales
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📌 Country Approval Specialist - FSP - Spain (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid