HUB Labeling Manager in Tadworth

Location: Walton Oaks

Contract Type: 12‐month Temporary Contract

Salary: £40,000-£45,000 per annum

JOB SUMMARY

The Manager is responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets, and for updating labelling documents on a timely basis according to internal SOPs and external regulatory requirements. This role may act as a Subject Matter Expert (SME) on local, regional and multi‐country regulatory labelling requirements and collaborate with other Hub Labelling Managers to share intelligence. Additionally, this role serves as an SME for the use and development of global tools, technologies and processes used to support label development, submission and approval - with a particular focus on digital solutions.

JOB RESPONSIBILITIES

• Monitors system data integrity and performs quality checks.
• Maintains system management for labelling activities including GDMS and approved labelling tracking systems.
• Produces labelling‐related documentation for submission to HAs such as tracked‐change versions, annotated labels, comparison tables, and annotated supporting documentation.
• Performs QC checks on work produced by colleagues.
• Identifies incremental improvements to labelling‐related processes and systems for exploration by senior labelling managers.
• Meets defined productivity, quality, and compliance targets as set by management.
• Utilizes regulatory labelling expertise to review, develop and deliver labelling documents for submission to Regulatory Authorities across markets / regions, requesting medical input as appropriate.
• Supports other deliverables within ILG responsibilities (e.g., readability testing).
• Contributes to projects involving current and new global tools, technologies, and processes supporting label development, submission, and approval - with a focus on digital solutions.
• Participates in research incubator initiatives involving automation, machine learning, BPM, etc.
• Collaborates with R&D leads on digital transformation initiatives aimed at integrating regulatory data, systems, and processes into a hyper‐efficient learning platform aligned to the GRS roadmap.
• Assists with labelling data analysis.
• Creates or enhances SharePoint web pages.
• Produces the full range of labelling documentation including NCE labels, product extensions, and complex revisions.
• Prepares responses to inquiries from colleagues during inspections and regulatory agency questions and represents during HA inspections.

QUALIFICATIONS / SKILLS

• Proficient in systems use consistent with business expectations; understands importance for maintaining compliance.
• Fluent in English (additional languages advantageous).
• Strong written and verbal communication skills.
• Understanding of SOPs, systems, and processes underpinning compliance and quality.
• Experience working with structured data (enterprise databases, Excel, SharePoint, Access).
• Strong understanding of labelling principles and regulatory frameworks.
• Strong knowledge of regulatory and labelling principles and local regulations.
• Life sciences or pharmacy graduate, or equivalent relevant professional experience.
• Ability to develop positive relationships across cultures and locations.
• Strong attention to detail and problem‐solving skills.
• Demonstrated technical aptitude and ability to learn new software quickly.
• Ability to quickly learn regulations and standards.
• Hands‐on registration experience in development, maintenance, or commercialization within Regulatory Affairs - ideally from a country office or regional regulatory perspective, especially understanding the implications of a CDS on LPDs.
• Ability to understand and manage regulatory implications of product strategy relating to labelling.
• Knowledge of global / regional regulatory guidelines, requirements, and clinical variations.
• Strong project management and analytical skills.

PREFERRED EXPERIENCE

• Ability to interpret and apply regional / local regulatory guidance (pre‐approval and post‐approval stages).
• Strong analytical, logical reasoning, and writing skills.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Regional Labelling Head and International Labelling Team Lead.
• Partners with PCOs, GRS, GRO and other platform lines as required.
• Supports global, GRS, GRO, and ILG initiatives as needed.

RESOURCES MANAGED

May manage personnel within a matrix structure and may have direct line management responsibility for 1-2 individuals.