Vertex Global Labeling Compliance and Operations Manager

1 week ago


London, Greater London, United Kingdom Vertex Full time

Job Title: Manager, Global Labeling Compliance and Operations

Job Summary:

Vertex is seeking a highly skilled Manager of Global Labeling Compliance and Operations to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring labeling compliance with regulatory requirements and global labeling processes.

Main Responsibilities:

  1. Labeling Compliance: Ensure labeling compliance with regulatory requirements and global labeling processes, providing support for inspection readiness and oversight of compliance with global labeling processes.
  2. Regional Labeling: Support the Regional Labeling Lead in the development and maintenance of regulatory labeling priorities and timelines for ROW markets, collaborating with artwork and other stakeholders to identify requirements and develop initial submission labeling artwork.
  3. Departmental Operations: Liaise with vendors to obtain support for ROW Labeling services, manage departmental projects to pursue process operations excellence, and develop and maintain SOP and WI.

Requirements:

  • Bachelor's degree in a life sciences field, with preference to higher degree.
  • Extensive experience in the pharmaceutical industry, in one or more of the following areas: Regulatory project management, Regulatory labeling development, Promotional product communications, and/or review for prescription pharmaceuticals.


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