RA CMC Associate Manager-II

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 :

• English.