Summary
About the Role
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 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.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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