Senior Regulatory Affairs Specialist for UK and Ireland
Core
Lead local Regulatory Affairs activities for medicinal products, medical devices, and cosmetics, ensuring compliance and supporting product registration and lifecycle management across the UK and Ireland.
Role type
Senior Regulatory Affairs Manager (UK & Ireland)
Builds
Product registrations, marketing authorisations, and lifecycle management for Galderma's dermatology portfolio
Domain
Pharmaceuticals and Dermatology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, post-approval lifecycle management, health authority interaction, promotional material compliance review, project management, stakeholder management
Preferred skills
Knowledge of post-Brexit regulatory landscape (Windsor Framework, IRP), experience with POM and P/OTC products
Technologies
Veeva PromoMats
Responsibilities
Lead regulatory activities for product registration and lifecycle management; Develop and execute local regulatory strategies in partnership with Global and Regional teams; Manage post-approval activities including marketing authorisation transfers, variations, and renewals; Support product launches by collaborating with Marketing, Commercial, Supply Chain, and Medical Affairs; Review and approve promotional and non-promotional materials for compliance; Coordinate local artwork and packaging updates; Build and maintain relationships with MHRA and HPRA; Monitor regulatory developments and assess impact on the portfolio
Seniority
Senior, hands-on IC
