Summary
Responsible for regulatory activities specifically related to Chemistry, Manufacturing and Control (CMC). Activities such as preparation and publication of REG CMC documentation for submission to Health Authorities. Additionally, interact with HA on REG CMC questions to support new products or post-market launches.
About the Role
Major Accountabilities ~ Formulate and lead a global CMC regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance ~ Lead and implement all global CMC submission activities (planning, authoring, review, coordination, submission) for assigned projects/deliverables. ~ Identify required documentation and any content, quality and/or timing issues for global submissions and negotiate delivery of source approved technical documents in accordance with project timelines. ~ Author and/or review high quality CMC documentation for HA submission, applying agreed global CMC regulatory strategies, current regulatory trends and guidelines. Ensure technical consistency and regulatory compliance, meeting agreed timelines and electronic 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; set objectives, prepare briefing books, coordinate and plan trials and risk mitigation plans. ~ Notification of technical complaints/adverse events/special case scenarios relating to Novartis products within 24 hours of receipt ~ Distribution of marketing samples (where applicable) Key Performance Indicators Responsible for regulatory activities specifically related to Chemistry, Manufacturing and Control (CMC). Activities such as preparation and publication of REG CMC documentation for submission to Health Authorities. Additionally, interact with HA on REG CMC questions to support new products or post-market launches. Work Experience ~Operations management and execution ~Project management ~International collaboration ~Multicultural experience Skills ~Negotiation skills ~Multifunctional teams ~Project management ~Regulatory compliance ~Risk management ~Documentation management ~Change control ~Risk assessment Language English
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Innovative Medicines
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Research & Development
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