Hybrid Regulatory Project Manager – Devices

at GSK

• Job title: Regulatory Project Manager – Devices
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, London, United Kingdom

About the role

• Regulatory Project Manager managing CMC regulatory projects for a devices portfolio at GSK. Collaborating with teams across supply, technical, and quality to ensure regulatory compliance.

Responsibilities

• Manage CMC (Chemistry, Manufacturing and Controls) regulatory projects for a portfolio of devices (standalone and all types of drug-device combinations).
• Work closely with colleagues across supply, technical, quality and local operating companies.
• Lead CMC regulatory activities for an assigned portfolio of devices across global markets.
• Develop and implement CMC regulatory strategies and plans for lifecycle management and change control.
• Prepare variation dossiers and lead responses to questions from regulatory authorities.
• Coordinate and facilitate cross-functional CMC Regulatory Matrix teams and represent CMC in wider project teams.
• Ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• Deliver CMC regulatory strategy to support major inspections (PAIs) with managerial support (occasionally).

Requirements

• Bachelor’s degree or equivalent in pharmacy, chemistry or a related scientific discipline.
• Experience in device related (standalone or all types of drug-device combinations) regulatory affairs or device development or manufacturing.
• Direct involvement in preparing regulatory submissions for device aspects.
• Practical understanding of manufacturing processes, control strategies and supply chain.
• Knowledge of global CMC regulatory requirements for device aspects and a track record of delivering compliant dossiers.
• Strong time management with the ability to prioritise and coordinate multiple activities to meet deadlines.
• Master’s in pharmacy, chemistry or a related scientific discipline (preferred).
• Professional regulatory affairs certification (preferred).
• Experience influencing cross-functional teams and engaging with regulatory authorities (preferred).
• Proven track record of developing global regulatory strategies affecting supply and product plans (preferred).
• Strong written and verbal communication skills with experience presenting to diverse stakeholders (preferred).
• Experience leading process improvement or change initiatives in regulatory or manufacturing settings (preferred).

Benefits

• competitive salary
• annual bonus based on company performance
• healthcare and wellbeing programmes
• pension plan membership
• shares and savings programme
• hybrid working model