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In this role you will coordinate local regulatory submissions and site activation in support of the integral start-up strategy. You will advise on MoH/EC regulatory strategies and lead local team efforts to expedite activation. You will collaborate with investigators and internal teams to align submissions with timelines and study files per SOPs.

You will manage country-specific documents, patient information materials, and tracking data to ensure compliant, timely site initiation. This role offers impact by accelerating global trials and ensuring adherence to regulatory standards.

Compensaciones / Beneficios

- Prepare, review and coordinate local regulatory submissions (MoH, EC, other national/local applications) aligned with global strategy
- Provide local regulatory strategy advice to internal clients
- Coordinate project-specific local SIA services and associated activities
- Serve as contact for investigators on submission-related activities
- Be the country-level key contact for ethical or regulatory submission activities




- Coordinate with internal departments to align site start-up with submission timelines and critical path for activation
- Lead local strategy and oversight to expedite site activation
- Achieve target cycle times for site activation
- Assist clinical team in Regulatory Compliance Review packages as applicable
- Develop country-specific Patient Information Sheet/Informed Consent Form documents
- Enter and maintain trial status information related to SIA activities in tracking databases
- Maintain country study files and filing processes per SOPs
- Stay updated on PPD SOPs, client SOPs/directives, and current xugodme regulatory guidelines

Responsabilidades

- Bachelor's degree or equivalent with relevant experience (2+ years)
- Knowledge of regulatory guidelines (MoH, EC) and local submission processes
- Ability to coordinate across internal functions and external investigators
- Strong written and oral communication skills
- Organizational and planning skills with attention to detail
- Leadership and negotiation abilities
- Proficiency with databases and documentation management
- English language proficiency

Requisitos principales

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📌 Country Approval Specialist (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid