Experteer Overview

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In this role, you will manage local regulatory submissions and coordinate activities aligned with our global 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 integral 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 xugodme 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