Regulatory Affairs & Pharmacovigilance Manager
Core
Oversee regulatory and pharmacovigilance operations for the Central Cluster (Romania, Moldova, Hungary, Czech Republic, Slovakia) to ensure compliance with local and international requirements and support product lifecycle management.
Role type
Manager, Regulatory Affairs & Pharmacovigilance
Builds
Regulatory strategies and safety surveillance systems for innovative therapies
Domain
Pharmaceuticals / Regulatory Affairs / Pharmacovigilance
Required skills
Regulatory strategy, Pharmacovigilance compliance, Health authority liaison, Vendor oversight, Risk management planning, Audit readiness, Cross-functional collaboration, Regional operations management
Preferred skills
PV auditing and inspection readiness experience
Technologies
EU GVP guidelines, ICSR management systems, Risk Management Plans (RMPs)
Responsibilities
Serve as primary Regulatory Affairs point of contact for national agencies; Shape regulatory strategies for market expansion; Oversee cluster pharmacovigilance activities including ICSR and literature monitoring; Manage implementation and oversight of Risk Management Plans; Maintain inspection and audit readiness; Partner with cross-functional teams for business decisions.
Seniority
Manager, hands-on IC