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Regulatory and Start Up Specialist - Poland

151200 - 280700 zł / rocznie

IQVIA

IQVIA seeks a Senior Associate Regulatory and Start-Up Specialist for its Warsaw office to manage site activation and regulatory compliance for clinical trials in Poland. This home-based role requires expertise in local regulations, contract negotiations, and stakeholder coordination across investigative sites and project teams.

Responsibilities

  • Serve as primary contact for investigative sites, Site Activation Managers, and project teams
  • Coordinate and execute country-specific site activation and regulatory activities
  • Prepare, review, and distribute regulatory documentation ensuring compliance and accuracy
  • Track submissions and approvals for regulatory filings, ethics committees, and clinical trial agreements
  • Monitor project milestones, identify risks, and support contract negotiations

Requirements

  • Bachelor's degree in Life Sciences or related scientific discipline
  • 3.5 to 5 years of clinical research experience
  • Demonstrated expertise in site activation and regulatory submissions
  • Strong knowledge of Clinical Trial Agreements and contract negotiations
  • Fluent in Polish with strong English communication abilities
  • Solid understanding of Polish and international clinical trial regulations

Compensation: zł151,200–zł280,700 base annually

Oferta pracy dodana 5 dni temu