Senior Lead, Global Regulatory Compliance Officer

il y a 2 semaines


VélizyVillacoublay, Île-de-France Dassault Systèmes Temps plein
About the Role

We are seeking a highly experienced Senior Lead, Global Regulatory Compliance Officer to join our team at Medidata. The successful candidate will be responsible for ensuring our company's Quality Management System and regulatory strategy are aligned with global regulatory expectations.

Key Responsibilities:

  • Engage with local regulatory agencies in the Japan region to ensure our interests are considered in regulatory guidance documents.
  • Collaborate with other departments to achieve our business goals, including Legal, Information Technology, Product Development, Sales, and RFX.
  • Grow our Unified Protection Strategy in collaboration with Information Security, Data Privacy, and Cloud Operations.
  • Balance project priorities and workload to ensure the team achieves overall customer-focused mission and objectives.

Requirements:

  • Strong understanding of regulations governing clinical trials, including ICH Good Clinical Practices (GCP) and regional distinctions.
  • Experience in clinical trial processes and technologies, including a working knowledge of trial master files and site master files.
  • Native level Japanese and fluent English.


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