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iqvia/iqvia3 days ago

Regulatory and Start Up Manager - Lithuania

$48,840–$73,260 year

On-site · Kaunas, Kaunas, Lithuania

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Direct and manage regulatory site activation and maintenance for selected studies or multi-protocol programs, including pre-award activities, oversight of scope of work, budget and resources. Develop, implement and maintain the Management Plan in alignment with the Scope of Work and Project Plan, ensuring collaboration across Regulatory & Site Activation and regional teams to deliver regulatory compliance. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials while ensuring compliance with regulatory requirements. Offer guidance on regulatory strategy and submissions, identify regulatory complexity, and contribute to regulatory intelligence to support studies. Mentor colleagues, maintain internal systems (CTMS), and support contract negotiations and documentation, with potential involvement in budget planning and client training. Proactive leadership in multi-regional and multi-protocol programs during start-up and maintenance, ensuring high standards of study approvals and quality control.

Required Qualifications

  • Bachelor's Degree Life sciences
  • 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role
  • Strong negotiation and communication skills
  • Good regulatory and/or technical writing skills
  • Good knowledge of ICH/GCP guidelines and applicable regulatory guidelines
  • Leadership and mentoring capabilities
  • Experience with CTMS and project management tools
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$49k – $73k / yr

Regulatory and Start Up Manager - Lithuania · iqvia/iqvia

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