Job Responsibilities
* Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance.
* Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
* Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
* Author and/or review high-quality CMC documentation for HA submission, 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.
* Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
* Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
* 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 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.
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