Senior Manager, Global Regulatory Affairs – Business Process
Core
Lead the design, development, implementation, and optimization of processes for the regulatory organization within a global healthcare company.
Role type
Senior Manager, Global Regulatory Affairs – Business Process
Builds
Regulatory systems and processes for a global portfolio of brand-name products, generics, and complex generics.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Affairs experience in Pharmaceutical/Biotech, Process design, Project management, Compliance knowledge, Data analytics/metrics utilization
Preferred skills
Six Sigma certification, Project management certification, Flowcharting (Visio)
Technologies
Visio
Responsibilities
Lead process design and optimization for the regulatory organization; Partner on development and monitoring of regulatory process adherence oversight; Utilize data analytics to identify process improvements; Collaborate with cross-functional teams on training and communication of new processes.
Seniority
Senior Manager, hands-on leadership
