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Regulatory Specialist

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Job Summary:

We are seeking a highly skilled Regulatory Specialist to join our team at Planet Pharma. As a Regulatory Specialist - Study Start Up, you will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites, while foreseeing and mitigating any risks.

Key Responsibilities:

  • Regulatory Planning and Execution: Prepare Clinical Trial Application Forms and submission dossiers for submission to regulatory authorities, ensuring compliance with local requirements and international regulations.
  • Regulatory Interactions: Interact with regulatory authorities for study purposes, handling responses and providing regular updates to the Start Up Lead and/or Regulatory Lead assigned to the study.
  • Project Management: Maintain project plans, trackers, and regulatory intelligence tools, ensuring alignment with assigned responsibilities and regulatory leadership.
  • Study Start-Up Planning: Prepare and support the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Site Management: Partner with assigned site CRA to ensure alignment in communication and secure site activation.

Requirements:

  • Strong knowledge of international and local/national regulations, company SOPs, and ICH-GCP principles.
  • Excellent communication and project management skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong analytical and problem-solving skills.