Regulatory Specialist

il y a 6 jours


Paris, Île-de-France Planet Pharma Temps plein

Job Summary:

We are seeking a highly skilled Regulatory Specialist to join our team at Planet Pharma. As a key member of our Regulatory department, you will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites.

Key Responsibilities:

  • Prepare and submit Clinical Trial Application Forms and submission dossiers to regulatory authorities, ensuring compliance with local requirements and international regulations.
  • Interact with regulatory authorities to address study-related queries and handle responses.
  • Provide regular updates on regulatory submissions to the Start Up Lead, Regulatory Lead, and Project Manager/Team.
  • Maintain project plans, trackers, and regulatory intelligence tools to ensure alignment with regulatory requirements.
  • Partner with site CRAs to ensure effective 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 independently and as part of a team.

What We Offer:

At Planet Pharma, we offer a dynamic and supportive work environment, opportunities for professional growth, and a competitive compensation package.



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