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Regulatory Compliance Manager
2 weeks ago
The position of Regulatory Compliance Manager at Novartis is a critical role that requires a professional with expertise in regulatory affairs. The ideal candidate will have a strong background in chemistry, manufacturing, and control (CMC) regulations, as well as experience in preparing and submitting regulatory documents to health authorities.
Main Responsibilities:
- To formulate and lead global CMC regulatory strategies that balance business benefits with regulatory compliance.
- To lead and implement all global CMC submission activities, including planning, authoring, reviewing, coordination, and submission for assigned projects and products.
- To identify required documentation and content, quality, or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
Requirements:
- Work Experience: Cross-cultural experience, operations management, and execution, collaborating across boundaries, and project management.
- Skills: Change Control, Cross-functional teams, Documentation Management, Negotiation Skills, Project Management, Regulatory Compliance, Risk Assessment, and Risk Management.
