Job Description Summary
Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition, interact with Health Authorities on REG CMC questions to support new product or post-marketed launches.
Job Description
Major accountabilities:
* 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 Health Authority 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.
Minimum Requirements:
Work Experience:
* Cross Cultural Experience.
* Operations Management and Execution.
* Collaborating across boundaries.
* Project Management.
Skills:
* Change Control.
* Cross-Functional Teams.
* Documentation Management.
* Negotiation Skills.
* Project Management.
* Regulatory Compliance.
* Risk Assessment.
* Risk Management.
Languages:
* English.
Skills Desired:
* Change Control.
* Cross-Functional Teams.
* Documentation Management.
* Negotiation Skills.
* Regulatory Compliance.
* Risk Assessment.
* Risk Management.
* Waterfall Model.
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