Regulatory And Site Start Up Specialist

Precision Medicine Group

Remote
Remote
Prepare submission dossiers for competent authorities
Interact with competent authorities and ethics committees
Maintain project plans and regulatory intelligence tools
Precision Medicine Group is seeking a Regulatory and Site Start Up Specialist to support clinical trial site activation processes while ensuring compliance with regulatory requirements. The role involves preparing necessary documentation and coordinating with various stakeholders to secure timely approvals

Job Summary

  • Responsible for the timely and quality delivery of site activation readiness within assigned countries/sites.
  • Prepares Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Maintains an updated knowledge of local clinical trial laws and regulations to ensure compliance.

Matching Summary

Match Score: 75

Precision Medicine Group is seeking a Regulatory and Site Start Up Specialist to support clinical trial site activation processes while ensuring compliance with regulatory requirements. The role involves preparing necessary documentation and coordinating with various stakeholders to secure timely approvals.

Skills & Requirements

Must-have

  • Prepare submission dossiers for Competent Authorities
  • Interact with Competent Authorities and Ethics Committees
  • Maintain project plans and regulatory intelligence tools
  • Manage collection of essential documents for site activation
  • Ensure compliance with ICH-GCP and local regulations
  • Maintain audit and inspection readiness

Nice-to-have

  • Passion for rare diseases and oncology
  • Strong communication and organizational skills
  • Familiarity with computerized information systems

Key Requirements

  • Bachelor's degree in life sciences or related field, RN, or equivalent experience
  • 1+ year as Regulatory or SU specialist in CRO or pharma/biotech
  • Fluency in English

Work Rights

Not specified

Tailored Resume

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