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Senior Manager Global Regulatory Affairs

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association Vollzeit
Job Summary

We are seeking an experienced Senior Global Program Regulatory Manager to join our team. In this role, you will be responsible for developing and implementing regulatory strategies that support the launch of new products and the maintenance of existing ones.

You will work closely with cross-functional teams to ensure compliance with regulatory requirements and to identify opportunities for process improvements.

Key responsibilities include:

  • Developing and implementing regulatory strategies that support product launches and maintenance.
  • Coordinating with cross-functional teams to ensure compliance with regulatory requirements.
  • Identifying opportunities for process improvements and implementing changes as needed.
  • Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
  • Facilitating preparation and finalization of briefing books and contributing to preparation of summary documents.
  • Developing and implementing plans for timely response to HA requests and coordinating responses.
  • May serve as local HA liaison depending on location (e.g., FDA or EMA).
  • Driving coordination, planning, and submission of dossiers in assigned regions worldwide.
  • Review of global dossier summary documents.
  • Developing and implementing plans to avoid/minimize clock stops during submission review.
  • Reviews, approves, and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
  • Reviews and submits Risk Management Plans.
  • May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
  • Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
  • Contributes to and often leads the development of departmental goals and objectives.
  • Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable).