Global RASSU Regulatory Start-Up Lead

CTI; Portugal; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

CTI is seeking a Global RASSU Lead to serve as an expert on regulatory requirements across EU and global regions. You will guide submissions, study start-up oversight, TMF review, and sponsor communication, ensuring alignment with ICH/GCP, GDPR, and country-specific regulations.

You will mentor teams, coordinate with sponsors and cross-functional groups, manage regulatory trackers, and drive audit readiness from planning through close-out, delivering timely regulatory milestones across regions.

Qualificações

• Bachelor’s degree in an allied health field or equivalent.
• Minimum 8 years of relevant research, regulatory, pharmaceutical, site, or CRO experience.
• Strong knowledge of regulatory submission processes globally and in EU.
• Excellent understanding of ICH/GCP, GDPR, and trial documentation standards.
• Experience with regulatory study start-up activities and TMF review.
• Experience supporting global/regional submissions.
• Strong organizational skills and ability to manage multiple priorities.
• Excellent written and verbal communication, with Sponsors and cross-functional teams.

Responsabilidades

• Define and oversee regulatory submission strategy with sponsors and regional/country teams.
• Oversee regulatory submissions to authorities and ethics committees; support EU/EEA through CTIS.
• Coordinate with regional teams to ensure timely national submissions and documentation.
• Oversee study start-up activities from planning to regulatory green light and close-out.
• Coordinate study documents, informed consent forms, and regulatory documents for accuracy.
• Maintain audit readiness and quality control across TMF/eTMF and regulatory trackers.
• Communicate with sponsors and project teams; identify risks and resolve blockers.
• Lead regulatory discussions and participate in meetings as assigned.

Conhecimentos

Regulatory strategy

Global/regional submissions

Project management

Communication

Organizational skills

Decision-making

Confidentiality

Fluent English

Formação académica

Bachelor’s degree in allied health field

Ferramentas

Regulatory tracking systems

eTMF/TMF systems

Microsoft Office

Descrição da oferta de emprego

CTI is seeking a Global RASSU Lead to serve as an expert on regulatory requirements across EU and global regions. You will guide submissions, study start-up oversight, TMF review, and sponsor communication, ensuring alignment with ICH/GCP, GDPR, and country-specific regulations.

You will mentor teams, coordinate with sponsors and cross-functional groups, manage regulatory trackers, and drive audit readiness from planning through close-out, delivering timely regulatory milestones across regions.