Quality and Regulatory Labelling Program Manager
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.
Location: Basingstoke, with occasional on-site attendance required (approximately once per month for meetings)
Pay Rate: £27 per hour
We are currently recruiting for a Quality and Regulatory Labelling Program Manager to support global labelling quality and regulatory initiatives within a highly regulated environment. This role will focus on ensuring compliant, accurate, and globally harmonised product labelling across international markets while driving continuous improvement and operational effectiveness.
This is a 9-month contract with the possibility of an extension.
Key Responsibilities:
Lead the planning, coordination, and execution of global labelling quality and regulatory initiatives
Support compliant implementation of labelling changes, artwork updates, UDI requirements, IFUs, translations, and market-specific labelling obligations
Collaborate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Packaging, Supply Chain, and Commercial functions
Manage program governance, timelines, deliverables, budgeting, risk assessments, and reporting activities
Lead labelling remediation projects, artwork harmonisation initiatives, and compliance transformation activities
Coordinate implementation of product labelling changes related to regulatory updates, product modifications, safety notices, recalls, or market expansion activities
Support inspection readiness activities and coordinate responses to regulatory observations and internal audit findings
Track commitments, corrective actions, and implementation milestones to ensure timely completion and sustained compliance
Drive continuous improvement initiatives focused on labelling accuracy, standardisation, compliance, and operational efficiency
Ensure labelling processes comply with applicable regulations and standards including FDA, EU MDR/IVDR, ISO, GMP, UDI, and regional market requirements
Technical Responsibilities:
Apply structured program and project management methodologies to regulatory and labelling initiatives
Manage integrated project plans including schedules, resources, dependencies, budgets, and implementation activities
Monitor completion of labelling change controls, artwork approvals, remediation activities, and compliance actions
Facilitate governance meetings, review boards, audit sessions, and executive reporting activities
Maintain audit records, artwork approvals, and version-controlled documentation in accordance with regulatory requirements
Support implementation and optimisation of labelling systems, artwork management tools, and compliance reporting platforms
Coordinate UDI implementation, product traceability initiatives, multilingual labelling requirements, and IFU updates
Identify and mitigate compliance, operational, and supply chain risks associated with labelling activities
Leadership Responsibilities:
Lead and coordinate cross-functional and geographically distributed teams
Build strong working relationships across Quality, Regulatory, Operations, Engineering, Procurement, and Commercial functions
Support stakeholders in prioritising activities and managing resource constraints
Deliver presentations and updates to senior leadership regarding programme status, compliance risks, and implementation progress
Promote a culture of quality, compliance, accountability, and continuous improvement
Coach and support project teams on programme management best practices and change management principles
Education:
Bachelor's and/or Master's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or related field required
MBA or advanced degree preferred
PMP or equivalent Project Management certification preferred
ASQ certifications (CQE, CQA, CMQ/OE) or RAC certification preferred
Lean Six Sigma certification preferred
Experience:
Minimum 7 years' experience managing complex programmes and strategic initiatives
Experience within Life Sciences, Medical Devices, Diagnostics, Biotechnology, Pharmaceutical, or other regulated industries preferred
Experience with labelling operations, artwork management, change control, audit management, and remediation programmes preferred
Strong understanding of product labelling lifecycle management including IFUs, packaging xsngvjr artwork, UDI, translations, and market-specific labelling requirements
Experience supporting regulatory inspection readiness and cross-functional transformation initiatives
Strong understanding of global labelling regulations and quality standards including FDA, EU MDR/IVDR, ISO, and GMP requirements
Experience with process improvement methodologies such as Lean or Six Sigma beneficial
Knowledge, Skills & Abilities:
Strong programme and project management capabilities including governance, scheduling, reporting, and risk management
Strong understanding of labelling operations, regulatory frameworks, and compliance processes
Familiarity with labelling systems, artwork management platforms, and electronic document management systems
Excellent analytical, problem-solving, and critical thinking skills
Strong communication and presentation skills with the ability to engage stakeholders at all levels
Proficient in MS Office applications including MS Project, Excel, and PowerPoint
Ability to independently manage strategic initiatives within complex matrix organisations
Ability to work collaboratively across multiple teams, functions, sites, and regions
Strong organisational skills with the ability to manage multiple priorities and deadlines effectively
Ability to travel up to 10-30% annually depending on business requirements
Brook Street NMR is acting as an Employment Business in relation to this vacancy.