Novartis recruits 01 FWCA Cluster Head Regulatory Affairs
- Formulate, lead and drive global CMC regulatory strategy drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.
- Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions.
- Identify the required documentation and any content, quality and/or timeliness 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 submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. -Lead, prepare and communicate CMC Risk Management Assessments, contingency plans and lessons learned on major submissions and escalate as appropriate.
- Initiate and lead Health Authority interactions and negotiations; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
- Provide strategic advice and direction within the department and cross-functionally through specialized assignments.
- Share regulatory knowledge with less experienced members of RA CMC department.
The position will be located ideally in Senegal, but can also be in Cameroon or Ivory Coast.
Operations Management and Execution Project Management Collaborating across boundaries Functional Breadth Cross Cultural Experience Managing Crises Critical Negotiations English NA
Closing date : 18 July 2021.
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