Novartis recruits a FWCA Cluster Head Regulatory Affairs.

Job Description

  • 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.

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Minimum requirements

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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