Sr. Principal Consultant, Regulatory Strategy and Advisory

We are looking for a Sr. Principal Consultant with expertise in Regulatory Strategy and Advisory, passionate about helping clients navigate transformational change, and having top-notch communication skills. The ideal candidate should have a rare blend of industry domain, process, technical and consulting skills, with experience in Regulatory and Clinical areas, and a deep understanding of processes related to health authority submissions, content authoring, labeling, lifecycle management of CMC, regulatory intelligence, and country-specific regulatory requirements.

Requirements

• Master's degree in a Life Science, Medical or Related discipline
• Minimum 12-15 years' experience in Drug development, Regulatory, Clinical Operation and Medical Devices
• Deep understanding of RIM systems (e.g., Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise)
• Knowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects

Benefits

• Full-time position
• Remote work