Global Regulatory Start-Up Lead — Fast-Track Trials

Novotech; Österreich; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

Novotech is seeking a Regulatory Start-Up Lead to manage country- and site-level submissions for clinical trials, ensuring adherence to ICH-GCP and local regulatory requirements across regions. You will guide start-up activities, coordinate with RSM/PM, and drive timely approvals while balancing budget and quality considerations.

The role emphasizes mentoring junior staff, cross-functional collaboration, and strategic alignment with project timelines and regulatory strategies in a dynamic,

Qualifikationen

• Bachelor's degree in Life Sciences or related field.
• 5+ years in Clinical Research or Regulatory Start-Up.
• Experience with country-level submissions and ICH-GCP.

Aufgaben

• Serve as the primary point of contact for country/site start up activities on allocated projects.
• Provide expertise on local regulations, ethics approvals and submission planning.
• Work within start-up plans, SOPs and ICH-GCP guidelines.
• Provide deadlines and timeline metrics for local authorities and ethics bodies.
• Collaborate with cross-functional teams to ensure timely regulatory deliverables.

Kenntnisse

Project management

Regulatory affairs

Stakeholder management

Communication

Problem solving

Mentoring

Ausbildung

Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline

Tools

eTMF

CTMS

Jobbeschreibung

Novotech is seeking a Regulatory Start-Up Lead to manage country- and site-level submissions for clinical trials, ensuring adherence to ICH-GCP and local regulatory requirements across regions. You will guide start-up activities, coordinate with RSM/PM, and drive timely approvals while balancing budget and quality considerations.

The role emphasizes mentoring junior staff, cross-functional collaboration, and strategic alignment with project timelines and regulatory strategies in a dynamic,