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HUB LABELLING MANAGER – French or German speaking (Walton Oaks based, hybrid)
Job Summary
The Hub Labelling Manager is responsible for the preparation, maintenance, and timely updating of local Product Labelling Documents (LPDs), Local Language Documents (LLDs), and Package Leaflet Documents (PLDs) for nationally registered products. The role ensures compliance with internal SOPs and global, regional, and local regulatory requirements.
The position acts as a Subject Matter Expert (SME) in regulatory labelling, supporting cross-region activities and contributing to the development and optimisation of global tools, systems, and digital solutions for label development, submission, and approval.
Key Responsibilities
* Develop, review, and update labelling documents for regulatory submissions across assigned markets and regions, ensuring accuracy, compliance, and timely delivery.
* Maintain and monitor labelling systems (including document management and tracking tools), ensuring data integrity, workflow efficiency, and adherence to quality standards.
* Prepare submission-ready labelling documentation, including annotated labels, tracked changes, comparison tables, and supporting materials.
* Perform quality control (QC) reviews of labelling documents and meet defined productivity, quality, and compliance targets.
* Respond to regulatory authority questions and support inspection activities related to labelling deliverables.
* Identify and contribute to continuous improvement of labelling processes, systems, and digital solutions.
* Participate in global initiatives and digital transformation projects, including automation, data analysis, and system enhancements (e.g. SharePoint and workflow tools).
* Support additional labelling deliverables such as readability testing, complex variations, and lifecycle management activities.
Qualifications & Skills
Education
* Degree in life sciences, pharmacy, or equivalent professional experience.
Experience (Required)
* Hands-on regulatory labelling experience supporting product development, registration, and post-approval maintenance.
* Strong understanding of global, regional, and local regulatory and labelling requirements.
* Ability to assess the regulatory implications of product strategy on labelling.
* Demonstrated attention to detail, problem-solving skills, and ability to manage multiple priorities.
* Experience working with structured data and enterprise systems (e.g. Excel, SharePoint, document management systems).
* Proven ability to work effectively across regions, cultures, and cross-functional teams.
Skills
* Strong written and verbal communication skills.
* Fluent English is required, and fluency in either German or French (written and spoken) is a mandatory requirement for this role.
* Strong technical aptitude with the ability to quickly learn systems, tools, regulations, and standards.
* Solid understanding of SOPs, compliance expectations, and regulatory labelling principles.
Preferred
* Experience interpreting regional and local labelling requirements across both pre-approval and post-approval stages.
* Strong analytical and writing capability
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