Summary
- Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.
About The Role
Major accountabilities:
- Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- As needed, coordinate /collect /store source documentation needed for direct submission to Health Authorities.
- Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
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.
Minimum Requirements
Work Experience:
- Cross Cultural Experience.
- Project Management.
- Operations Management and Execution.
- Collaborating across boundaries.
Skills
- Documentation Management.
- Lifesciences.
- Operational Excellence.
- Regulatory Compliance.
Languages
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