Regulatory Project Manager - Devices

You will manage CMC (Chemistry, Manufacturing and Controls) regulatory projects for a portfolio of devices (standalone and all types of drug-device combinations). You will work closely with colleagues across supply, technical, quality and local operating companies. We value clear thinkers who build strong relationships, solve problems and keep patients’ needs at the centre. This role offers visible impact, development opportunities and the chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

• Lead CMC regulatory activities for an assigned portfolio of devices (standalone and all types of drug-device combinations) across global markets.
• Develop and implement CMC regulatory strategies and plans (with managerial support) 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.
• Ensures regulatory compliance is maintained and shares best‑practices and learnings within the CMC Regulatory teams and other impacted functions.
• Will sometimes deliver CMC regulatory strategy to support major inspections (PAIs) with managerial support.

• 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.
• Professional regulatory affairs certification.
• Experience influencing cross-functional teams and engaging with regulatory authorities.
• Proven track record of developing global regulatory strategies affecting supply and product plans.
• Strong written and verbal communication skills with experience presenting to diverse stakeholders.
• Experience leading process improvement or change initiatives in regulatory or manufacturing settings.

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Job Description , as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.