Portugal Regulatory & Start-Up Specialist Site Activation

IQVIA LLC; Lisboa; Presencial; EUR 40 000 - 60 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Regulatory and Start Up Specialist in Portugal to perform country-level Site Activation tasks in line with local and international regulations, SOPs and project requirements. The role requires EC/RA submissions experience and strong knowledge of local regulatory requirements, with fluency in Portuguese.

The position is based in Portugal and involves collaboration with cross-functional teams to ensure timely regulatory deliverables.

Qualificações

• Bachelor’s Degree in life sciences or related field and 3 years’ clinical research or equivalent.
• Knowledge of GCP/ICH and regulatory guidelines.
• Understanding of local regulatory requirements and drug development.

Responsabilidades

• Serve as SPOC for sites and project teams to ensure timelines and quality of deliverables.
• Perform site activation activities per applicable regulations, SOPs and work instructions.
• Prepare site regulatory documents and review for completeness and accuracy.
• Maintain internal systems, databases and trackers with project-specific information.

Conhecimentos

Regulatory submissions

Clinical research coordination

Formação académica

Bachelor's degree in life sciences

Descrição da oferta de emprego

IQVIA is seeking a Regulatory and Start Up Specialist in Portugal to perform country-level Site Activation tasks in line with local and international regulations, SOPs and project requirements. The role requires EC/RA submissions experience and strong knowledge of local regulatory requirements, with fluency in Portuguese.

The position is based in Portugal and involves collaboration with cross-functional teams to ensure timely regulatory deliverables.