RA CMC Manager

Key performance indicators :

• Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.
• No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
• Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
• Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
• Maintains collaborative partnerships with stakeholders.

Minimum Requirements :

Work Experience :

• Cross Cultural Experience.
• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.

Skills Required

Regulatory Compliance, Risk Management