Regulatory Document Specialist

4 dni temu


Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat

About the Job

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Innovaderm. As a key member of our regulatory department, you will be responsible for ensuring compliance with applicable EU regional regulations and guidelines.

The ideal candidate will have a strong background in clinical research, excellent knowledge of GCP and ICH standards, and fluency in English. You will work closely with project teams and external partners to prepare and submit regulatory documentation, including CTAs and patient information sheets.

  • Preparation and submission of regulatory documents and CTA packages
  • Coordination of regulatory timelines and deadlines for assigned projects
  • Review and approval of regulatory documents prepared by subcontractors
  • Point of contact for sponsors and project management teams

Requirements

  • Bachelor's degree in a scientific discipline
  • Minimum 2-3 years of experience in clinical research, preferably in a CRO or Pharma environment
  • Excellent knowledge of EU regional regulatory guidelines
  • Fluency in English and additional languages an asset

What We Offer

  • Permanent full-time position
  • Flexible schedule
  • Vacation and home-based work arrangement
  • Ongoing learning and development opportunities


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