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Manager, Global Labeling Compliance and Operations-Remote Eligible, London Client:
Location: London, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: c0b8520394ea
Expiry Date: 06.08.2025
Job Description: Position Summary:
The Global Labeling Team at Vertex is seeking a highly motivated Manager of Labeling Compliance and Operations - Rest of World (ROW). The candidate should understand global labeling and ensure compliance with regulatory requirements and processes. Responsibilities include supporting inspection readiness, managing regional product labeling, reviewing packaging artwork, and liaising with stakeholders in commercial and supply chain.
The candidate will develop strong matrixed relationships and support the Regional Labeling Lead in collaboration with global regulatory affairs and cross-functional teams to develop labeling strategies. The role requires a proactive individual capable of leading, influencing, and collaborating effectively.
Key Responsibilities:
Support the Regional Labeling Lead in developing and maintaining regulatory labeling priorities for ROW markets.
Collaborate on artwork and stakeholder requirements for new markets.
Manage creation, review, and approval of packaging and labeling for ROW.
Draft regulatory responses for package component labeling in ROW countries.
Coordinate label changes with stakeholders.
Assess regulatory impact of label changes.
Manage deviations and CAPAs related to labeling in ROW.
Support development and archiving of regional product labeling documents.
Communicate approved labeling to ROW markets.
Perform proofreading and QC tasks as needed.
Department Operations:
Coordinate with vendors for translation and other labeling support.
Manage projects to improve processes, including SOP and WI updates.
Compliance:
Oversee compliance with global and regional labeling processes.
Track updates and deviations, maintain records.
This position reports to the Global Head of Regulatory Labeling Compliance and Operations, GRA.
Skills/Experience:
Knowledge of pharmaceutical regulations, especially labeling and packaging.
Strong planning, organizational, analytical, proofreading, and decision-making skills.
Experience leading process improvements and managing multiple projects.
Leadership and motivational abilities.
Independent judgment and decision-making skills.
Excellent communication skills.
Proficiency with electronic document management systems.
Experience with pharmaceutical labeling regulations in ROW markets, especially Middle East, Asia, and Balkans, is desirable.
Experience with Quality Management Systems, change control, deviation, and CAPA management.
Familiarity with RIM management system and label tracking tools is desirable.
Bachelor’s degree in a life sciences field preferred, with higher degrees advantageous.
Extensive experience in the pharmaceutical industry in regulatory project management, labeling development, or related areas.
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