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Global Regulatory Leader

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Novartis Farmacéutica Vollzeit
Job Overview

The role of the Senior Global Program Regulatory Manager is to oversee the development and implementation of regulatory strategies for product registration, progress reports, supplements, amendments, and periodic experience reports. This position requires a strong understanding of global regulatory requirements and the ability to provide strategic direction to teams on interaction and negotiation with regulatory agencies.

Main Responsibilities
  • Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.
  • Provides strategic product direction to teams on interaction and negotiation with regulatory agencies.
  • Serves as a regulatory liaison on the project team throughout the product lifecycle.
  • Ensures rapid and timely approval of new drugs, biologics/biotechnology, and/or medical devices and continued approved status of marketed drugs or medical devices.
  • Coordinates, reviews, and may prepare reports for submission.

Key Performance Indicators
  • Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
  • Identification of main HA issues - Participation in relevant regulatory Boards leading to valuable input from these Boards.
  • Successful participation in HA interactions to achieve business objectives.
  • Adherence to Novartis policy and guidelines - Project & stakeholder feedback.