Strategic Regulatory Director

3 settimane fa

Milano, Lombardia, Italia Viatris A tempo pieno
Developing Regulatory Strategies for a Better Future

We are seeking a highly skilled Director Regulatory Strategist to join our team at Viatris. As a key member of our regulatory affairs team, you will play a crucial role in developing and implementing global and regional regulatory strategies for complex projects and products.

Your responsibilities will include:

  • Developing and implementing global and regional regulatory strategies and implementation plans for complex projects and products.
  • Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome.
  • Partnering with project teams and other stakeholders to ensure required regulatory contributions meet business needs and quality standards and are provided in accordance with agreed timelines.
  • Providing regulatory input to clinical development programs, risk/benefit assessments, and for target label development.
  • Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and contribute to the development and maintenance of local labels as appropriate.
  • Ensuring regulatory plans are monitored, progress is communicated to Senior Management, and any risks (from emerging technical data, changing internal objectives, or external impacts) are mitigated.
  • Developing fit-for-purpose submission packages in collaboration with partner lines.
  • Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects and products, and that these regulatory positions supporting the business are championed, communicated, and executed on time to the required quality standards.

If you have a strong background in regulatory affairs and a passion for developing strategic plans that drive business success, we encourage you to apply for this exciting opportunity.

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