Global RASSU Regulatory Lead

CTI Clinical Trial and Consulting Services; Lisboa; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

CTI Clinical Trial and Consulting Services in Portugal is seeking a Global RASSU Lead to serve as the regulatory SME for clinical trial regulatory requirements. You will align with CTI and sponsor SOPs, ICH/GCP, and applicable regulations, while supporting regulatory document oversight, eTMF/TMF review, audits, training, and mentoring across regional and country teams.

The role oversees submission strategy, regulatory tracking, and green-light processes from study start-up to close-out.

Qualificações

• Bachelor’s degree in allied health field or equivalent.
• 8+ years in research, regulatory, pharmaceutical, site, or CRO.
• Strong knowledge of EU CTR, CTIS, MHRA, Ethics Committee/IRB/IEC processes and country regulations.
• Excellent understanding of ICH/GCP, SOPs, GDPR, and trial documentation standards.
• Experience with regulatory study start-up activities, including document preparation and regulatory tracking.
• Experience supporting or overseeing global and regional clinical trial submissions.
• Excellent written and verbal communication; ability to collaborate with sponsors and cross-functional teams.
• Fluent in English (spoken and written).

Responsabilidades

• Serve as a regulatory SME, ensuring alignment with country-specific requirements.
• Oversee regulatory submissions and study start-up oversight.
• Coordinate study documentation and quality control.
• Maintain regulatory trackers and TMF/eTMF systems.
• Support sponsor communications and cross-functional collaboration.
• Ensure audit readiness and regulatory compliance.
• Lead process improvement and operational excellence.

Conhecimentos

Regulatory expertise

Communication skills

Organizational skills

Cross-functional collaboration

Regulatory tracking systems

Formação académica

Bachelor's degree in allied health

Ferramentas

eTMF/TMF systems

Regulatory tracking systems

Microsoft Office

CTIS submissions

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services in Portugal is seeking a Global RASSU Lead to serve as the regulatory SME for clinical trial regulatory requirements. You will align with CTI and sponsor SOPs, ICH/GCP, and applicable regulations, while supporting regulatory document oversight, eTMF/TMF review, audits, training, and mentoring across regional and country teams.

The role oversees submission strategy, regulatory tracking, and green-light processes from study start-up to close-out.