Global Labeling Compliance and Operations Manager

2 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
Job Description:

Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT, seeks a highly motivated Manager of Global Labeling Compliance and Operations for their team. This position will be responsible for ensuring labeling compliance with regulatory requirements and global labeling processes.

Key Responsibilities:
  • Product Operations:
    • Support the Regional Labeling Lead (RLL) 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, 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.
    • Ownership of labeling deviations and CAPA's for ROW markets.
    • Support the Regional Labeling Lead (RLL) in developing the 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.
  • 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).
  • 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 is a salaried position offering an estimated annual salary of $120,000-$180,000, depending on experience, location, and qualifications.

Requirements:
  • Bachelor's degree in a life sciences field, preferably 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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