Focus on providing and driving creation of global CMC regulatory documentation for projects/products covering development, registration and approval/post approval activities.
Formulate and drive global CMC regulatory strategy for development projects or marketed products, conduct risk assessments and develop mitigation strat-egies for cell and gene therapy products. Represent Global Regulatory CMC on interdisciplinary project teams and main-tain sound working relationships with partners and customers. Lead global CMC submission activities including identifying required content to ensure compliance in meeting global regulatory requirements. Author and/or review CMC documentation for Health Authority submissions. Coordinate and lead FDA interactions and negotiations and support global Health Authority interactions for CMC topics. Possess knowledge on current regulatory guidelines and requirements in all global regions. Support business objectives and initiatives.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology) or equivalent required English Advanced Degree in Science desirable 3 years pharmaceutical industry experience in CMC drug development, QA/QC, and/or Technical Operations; experience in cell and gene therapy development and/or manufacture, testing 2-6 years regulatory CMC experience in biologics regulatory CMC, 1-3 years experience in cell and gene therapy regulatory CMC Working knowledge of global biologics and cell and gene therapy regulatory requirements and experience in regulatory submissions, approvals, and product life cycle management. Good oral and written communication skills Strong organizational skills Proven excellence in working on interdisciplinary teams Demonstrated leadership skills
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