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Regulatory Project Manager

il y a 1 mois

Paris, Île-de-France Groupe ProductLife Temps plein
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Groupe ProductLife. As a key member of our Regulatory Affairs department, you will be responsible for coordinating activities for one of our main French clients and ensuring compliance with international and EU regulations.

Key Responsibilities:

  • Coordinate activities for the client and ensure compliance with regulatory requirements
  • Provide guidance and support to the client on regulatory strategies and requests
  • Manage CCDS and Product Information updates
  • Manage CEP and ASMF regulatory assessments and variation packages
  • Respond to internal requests for technical and regulatory information

Requirements:

  • Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree (PharmD)
  • International markets LifeCycle Maintenance (LCM) experience
  • Experience in managing CCDS and Product Information updates
  • Experience in managing CEP and ASMF
  • Strong computer skills, including MS Office applications and data management systems
  • Fluency in French and English