Key performance indicators:
- Produces high quality regulatory documentation -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 & accurate information / communication about project documentation specific issues within own department and to key stakeholders.
- RA CMC regulatory documentation follows Novartis guidelines & meets regulatory guidelines.
- Builds & maintains collaborative partnerships with stakeholders.
