Global Labeling Compliance Manager

2 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly motivated Manager of Global Labeling Compliance and Operations for Rest of World (ROW) markets at Lifelancer. This role involves ensuring global labeling compliance with regulatory requirements, providing support for inspection readiness, and overseeing regional product labeling.

Key Responsibilities:
  • Product Operations:
    • Support the Regional Labeling Lead in developing and maintaining regulatory labeling priorities and timelines for ROW markets.
    • Collaborate with artwork and stakeholders to identify requirements and develop initial submission labeling artwork for new markets.
    • Manage ROW packaging and labeling creation, review, 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 CAPA's for ROW markets.
    • Support the Regional Labeling Lead in developing regional product labeling as needed and tracking key documents.
    • Communicate approved labeling to ROW markets to support healthcare professionals.
  • Department Operations:
    • Liaise with vendors to obtain support for ROW Labeling services such as translations.
    • Manage departmental projects to pursue process operations excellence (includes associated SOP and WI development and maintenance).
  • Compliance:
    • Oversight of compliance with global labeling processes and supporting associated regional labeling for inspection readiness.
Requirements:
  • Possesses working knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focusing on 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 familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved, and in-use labeling.
  • Desirable experience: Pharmaceutical labeling regulations in ROW markets, particularly Middle East, Asia, and Balkans (non-EU member countries), Quality Management Systems for change control, deviation, and CAPA management, use of RIM management system, and label tracking tools.
What You'll Get:
  • $120,000 - $150,000 per year salary range.

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