Regulatory Intelligence Senior Specialist
Core
Monitor and pre-assess global health authority requirements for human and veterinary medicines to safeguard compliance and support Lonza's CDMO business operations.
Role type
Senior Regulatory Intelligence Specialist
Builds
Global regulatory intelligence databases, dashboards, and actionable summary reports
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Global regulatory framework knowledge (FDA, EMA, MHRA, PMDA, ICH, PIC/S), Regulatory Intelligence experience, Analytical synthesis, BI dashboard tools (Power BI, Tableau), Project management
Preferred skills
Pharmaceutical or biotech industry experience, Chemistry/Biology/Biotechnology degree, EU business hours availability
Technologies
Power BI, Tableau
Responsibilities
Conduct worldwide regulatory intelligence surveillance, Partner with global Regulatory SMEs and cross-functional teams, Monitor regulatory updates and convert requirements into actionable reports, Facilitate cross-functional intelligence assessment meetings, Maintain regulatory intelligence databases and dashboards, Develop internal training materials for regulatory intelligence
Seniority
Senior, hands-on IC
