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Hub Labeling Manager 📍 Walton Oaks, 37 hours per week 📅 Fixed-term contract: 12 months
About the Role
The Hub Labeling Manager will oversee the preparation of Labeling Product Dossiers (LPDs), associated Labeling [Local/Regional] Documents (LLDs) and Product Label Drafts (PLDs) for nationally registered pharmaceutical products in assigned markets. They will ensure these documents are updated timely and accurately in line with internal Standard Operating Procedures (SOPs) and external regulatory requirements.
Key responsibilities also include:
- Acting as a Subject Matter Expert (SME) on local, regional, and multi-country regulatory labeling requirements, collaborating with peers to share intelligence.
- Serving as an SME for labeling tools, technologies, and processes, with a special focus on digital solutions to improve efficiency and compliance.
Responsibilities
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System Management:
- Oversee Global Document Management System (GDMS) and approved labeling tracking systems.
- Maintain workflow management tools and email mailboxes ensuring smooth operations.
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Quality & Compliance:
- Monitor data integrity and perform quality checks on labeling-related documentation.
- Produce accurate, non-complex LPDs, LLDs, and PLDs while adhering to regulatory principles.
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Documentation & Submission:
- Prepare additional submission documents for Health Authorities (HAs), such as:
- Track change versions
- Annotated labels
- Comparison tables
- Annotated supporting documentation
- Perform Quality Control (QC) checks on colleagues' work.
- Prepare additional submission documents for Health Authorities (HAs), such as:
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Process Improvement:
- Identify incremental improvements in labeling processes for discussion with senior managers.
- Leverage experience to assist with implementing new systems and tools.
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Regulatory Expertise:
- Review, develop, and submit labeling documents to Regulatory Authorities across markets.
- Collaborate with medical experts where necessary to ensure accuracy.
- Ensure compliance with product labeling regulations and strategic implications of the Core Data Sheet.
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Performance & Productivity:
- Meet productivity, quality, and compliance targets set by management.
Qualifications
- Education: Graduate in Life Sciences or Pharmacy, or equivalent qualification and experience.
- Language Skills: Fluency in English is essential; multi-language skills are advantageous for international markets.
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Required Skills & Experience
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Technical Proficiency:
- Experience with structured data systems (e.g., GMCS/IMDS, enterprise databases, MS Excel, MS SharePoint, MS Access).
- Capability to learn new software tools quickly and adapt to evolving digital solutions.
- Regulatory knowledge of key principles, local and global/regional guidelines, and pre- and post-approval processes.
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Regulatory Expertise:
- Hands-on experience with registration procedures, including dossier submission, product maintenance, and commercialization.
- Familiarity with Regulatory Affairs (preferably from a Country Office or Multi-country Regulatory Strategy perspective).
- Understanding of Clinical Variation and Core Data Sheet implications on labeling.
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Soft Skills:
- Ability to build strong relationships across diverse cultures and locations.
- Strong attention to detail, problem-solving, and analytical writing skills.
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Motivation:
- Proven ability to manage regulatory implications of product strategy and interpret regional/local guidance.
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