Compliance Manager

4 weeks ago

London, Greater London, United Kingdom Vertex Pharmaceuticals Full time
Global Labeling Compliance and Operations Manager

Job Summary:

Vertex Pharmaceuticals is seeking a highly motivated Global Labeling Compliance and Operations Manager to join our team. The successful candidate will be responsible for ensuring labeling compliance with regulatory requirements and global labeling processes, providing support for inspection readiness, and overseeing regional product labeling.

Key Responsibilities:

  1. Product Operations
    • Support the Regional Labeling Lead in developing and maintaining regulatory labeling priorities and timelines for ROW markets.
    • Collaborate with artwork and other stakeholders to identify requirements and develop initial submission labeling artwork for new markets.
    • Manage ROW packaging and labeling creation, review, and endorsement through labeling governance and approval.
    • Author regulatory response documents for package component labeling responses in ROW countries.
    • Collaborate with artwork and supply chain stakeholders to plan and implement label changes.
    • Provide regulatory labeling impact assessments for ROW change control records.
    • Own labeling deviations and CAPAs for ROW markets.
    • Support the Regional Labeling Lead in developing regional product labeling as needed, and for tracking and archiving key documents.
    • Responsible for the process and communication of approved labeling to ROW markets to support HCPs.
    • Proofread and departmental QC, as needed.
  2. Department Operations
    • Liaise with vendors to obtain support for ROW Labeling for services such as translations.
    • Manage departmental projects to pursue process operations excellence (includes associated SOP and WI development and maintenance).
  3. Compliance:
    • Accountable for oversight of compliance with global labeling processes and supporting associated regional labeling for inspection readiness. This includes tracking of package component labeling updates and internal labeling content deviations as well as maintenance of controlled records.

This position will report to the Global Head of Regulatory Labeling Compliance and Operations, GRA.

Requirements:

  • Possesses a working knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging.
  • Excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills.
  • Experience leading process improvement projects.
  • Experience managing projects or coordinating multiple activities at once.
  • Ability to lead and motivate others.
  • Ability to drive projects to completion.
  • Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.
  • Possesses excellent written and verbal communication skills.
  • Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved, and in-use labeling.
  • Experience with pharmaceutical labeling regulations in ROW markets, with a focus on Middle East, Asia, and Balkans (non-EU member countries) is desirable.
  • Experience in Quality Management Systems for change control, deviation, and CAPA management.
  • Experience in use of RIM management system is desirable.
  • Experience with label tracking tools is desirable.

Education:

  • Bachelor's degree (preferably 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 or similarly regulated industry required.

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