Regulatory Affairs Manager
Core
Managing regulatory activities and client projects for human and veterinary medicinal products, medical devices, cosmetics, food supplements, and herbal products in the Polish market.
Role type
Senior Regulatory Affairs Manager (Client-facing)
Builds
Regulatory submissions, marketing authorizations, and lifecycle management for diverse healthcare products in Poland.
Domain
Healthcare / Life Sciences / Polish Regulatory Affairs
Deliverable
client delivery
Required skills
Polish regulatory strategy, submission and lifecycle management, client relationship management, project coordination, regulatory intelligence, audit readiness, change control analysis
Preferred skills
Medical devices/cosmetics/supplements regulatory knowledge, Veeva Vault, Regulatory Affairs certification
Technologies
Veeva Vault
Responsibilities
Develop and maintain strong client relationships; lead regulatory activities to obtain and maintain marketing authorizations; prepare and review regulatory documentation for submissions and renewals; communicate with clients and Polish Health Authorities; plan and execute client projects per KPIs; coordinate project teams and external partners; provide regulatory consultancy on strategy and procedure management; monitor regulatory intelligence; present seminars and lectures; support department strategy and process optimization; review change controls and quality events; maintain audit-ready tracking tools.
Seniority
Manager, hands-on IC with client leadership