Thermo Fisher Scientific seeks a Country Approval Specialist in Madrid to manage local regulatory submissions and coordinate site activation for clinical trials across multiple countries. This role involves preparing regulatory documentation, providing local strategy guidance, and ensuring alignment between submission and site activation timelines.
Responsibilities
- Prepare, review, and coordinate local regulatory submissions aligned with general strategy
- Provide local regulatory strategy advice to internal stakeholders
- Serve as primary country-level contact for regulatory and ethical submission matters
- Coordinate site startup activities with internal departments to meet critical path timelines




- Develop country-specific patient information and informed consent form documents

Requirements
- Bachelor's degree or equivalent formal academic/vocational qualification
- 2+ years of relevant experience in regulatory or clinical trial operations
- Strong written and oral communication skills in English
- Knowledge of regional and national regulatory guidelines and EC regulations
- Excellent organizational, planning, and attention to detail capabilities
- Proficiency with computer systems and ability to learn specialized software
- Basic medical terminology and therapeutic area knowledge

📌 Dynamics Specialist (España)
🏢 Thermo Fisher Scientific
📍 España