Hub Labelling Manager
Location: Walton Oaks, Surrey (Hybrid)
Contract: 12 Months
Hours: 37 hours per week
Languages: English essential; French and German preferred
About the Role
We are seeking an experienced Hub Labelling Manager to join a global regulatory affairs team supporting pharmaceutical products across multiple international markets. This role is responsible for the preparation, maintenance, and management of local and global labelling documentation, ensuring compliance with regulatory requirements and internal procedures.
The successful candidate will act as a subject matter expert on labelling activities, supporting regulatory submissions, process improvements, and digital transformation initiatives while collaborating with stakeholders across global markets.
Key Responsibilities
- Prepare, maintain, and update Local Product Documents (LPDs), Local Label Documents (LLDs), and Product Label Documents (PLDs) in accordance with regulatory requirements and internal SOPs.
- Produce supporting labelling documentation, including annotated labels, comparison tables, track-change versions, and submission-ready documentation.
- Maintain labelling activities within document management and workflow systems, ensuring data integrity and compliance.
- Perform quality control reviews of labelling documentation produced by colleagues.
- Support regulatory submissions and respond to regulatory authority queries where required.
- Assist with labelling-related activities such as readability testing and compliance documentation.
- Contribute to continuous improvement initiatives, identifying opportunities to enhance labelling processes and systems.
- Support digital transformation projects involving automation, machine learning, data management, and process optimisation.
- Assist with labelling data analysis and development of SharePoint sites and digital solutions.
- Collaborate with cross-functional teams to ensure high-quality, compliant, and timely delivery of labelling activities.
Skills & Experience
Essential
- Degree in Life Sciences, Pharmacy, or a related discipline, or equivalent industry experience.
- Fluency in English, with French and/or German language skills highly desirable.
- Experience within Regulatory Affairs, Labelling, or related pharmaceutical regulatory functions.
- Strong understanding of regulatory labelling principles and requirements.
- Experience preparing and maintaining regulatory labelling documentation.
- Knowledge of local, regional, and global regulatory guidelines and requirements.
- Strong analytical, problem-solving, and attention-to-detail skills.
- Excellent written and verbal communication skills.
- Proven ability to manage multiple priorities and work effectively within global teams.
- Experience using enterprise systems and databases, including MS Excel and SharePoint.
Desirable
- Experience supporting product registrations, lifecycle management, and commercialization activities.
- Understanding of Core Data Sheets and their impact on local labeling requirements.
- Knowledge of pre-approval and post-approval labelling processes.
- Experience with digital transformation, process automation, or data-driven regulatory initiatives.
- Familiarity with regulatory inspections and health authority interactions.
What We’re Looking For
The ideal candidate will be highly organised, detail-oriented, and capable of working in a fast-paced global environment. You will possess strong regulatory and labelling expertise, a collaborative approach, and a keen interest in leveraging technology and process improvements to drive efficiency and compliance.
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