Senior Regulatory Affairs Specialist for UK and Ireland

Overview

In this role, you will lead regulatory activities for Galderma’s medicinal products across the UK and Ireland, ensuring regulatory compliance and lifecycle management. You will shape local regulatory strategy in partnership with Global and Regional teams and drive post-approval activities, including variations and PSURs. You will collaborate with Marketing, Commercial, Supply Chain, Medical Affairs and Pharmacovigilance to support launches and ongoing availability. You will build strong relationships with MHRA and HPRA, monitor regulatory developments, and contribute to inspections. This is a key partnership role that combines regulatory rigor with cross-functional impact to grow Galderma’s

Responsibilities

• Lead regulatory activities for registration and lifecycle management across UK & Ireland
• Develop and execute local regulatory strategies with Global/Regional teams
• Manage post-approval activities (variations, renewals, PSURs/PBRERs, changes to registered details)
• Support product launches and ongoing availability through cross-functional collaboration
• Review and approve promotional/non-promotional materials for regulatory compliance
• Coordinate local artwork/pack updates via Veeva PromoMats
• Build/maintain relationships with MHRA and HPRA (submissions, pre-submission meetings, post-approval interactions)
• Monitor regulatory developments and assess impact on portfolio
• Contribute regulatory expertise to inspections and ensure compliance with legislation and procedures

Key requirements

• Degree-level qualification in Life Sciences or related field
• Minimum 5 years of hands-on Regulatory Affairs experience (pre- and post-approval)
• Experience in local affiliate environment covering UK and Ireland
• Strong experience with medicinal products (POM and P/OTC)
• Proven interaction with MHRA and HPRA (submissions, pre-submission meetings, post-approval)
• Strong understanding of UK & Ireland pharmaceutical regulatory environment
• In-depth knowledge of post-Brexit landscape (Windsor Framework, IRP)
• Experience in multinational pharmaceutical environment and cross-functional collaboration
• Strong project management, communication and stakeholder management skills
• Fluency in English

• project management
• stakeholder management
• proactive collaboration
• Regulatory strategy development
• Regulatory submissions and interactions (MHRA/HPRA)
• Post-approval activities (variations, renewals, PSURs)

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