Compliance

• support the execution of multi-product global regulatory CMC for marketed products
• contribute to the preparation and submission of regulatory CMC documentation
• provide regulatory support to various cross functional teams
• execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on EU / UK / Swiss
• reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• works with regulatory colleagues in development of global regulatory CMC strategies and submissions
• participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

Regulatory CMC Consultant

Regulatory Manager – Senior Regulatory Manager, Clinical Trials

Compliance Specialist