Regulatory Project Manager – Devices
GSK
full-time
Posted on:
Location Type: Hybrid
Location: London • United Kingdom
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC regulatory projectsregulatory submissionsmanufacturing processescontrol strategiesglobal CMC regulatory requirementsregulatory compliancelifecycle managementchange controlvariation dossiersdevice development
Soft skills
time managementprioritizationcoordinationinfluencing cross-functional teamsengaging with regulatory authoritiesstrong written communicationstrong verbal communicationpresentation skillsprocess improvementchange initiatives
Certifications
professional regulatory affairs certification