Regulatory Affairs Senior Associate

4 settimane fa


Milano, Lombardia, Italia Pfizer A tempo pieno
Job Summary

We are seeking a highly skilled Senior Associate to join our Early Phase Regulatory Affairs team in the EU region. As a key member of our Global Regulatory Strategic Team, you will provide regional strategic expertise and lead the implementation of EU regulatory strategies for assigned projects/products.

Key Responsibilities
  • Ensure timely submissions and approvals in the EU region
  • Lead and implement EU regulatory strategies in agreement with key stakeholders
  • Partner with project teams to ensure required regulatory contributions
  • Monitor and communicate regulatory plans and progress to GRL and Senior Management
  • Develop and maintain constructive working relationships with Health Authority contacts in the EU region
Qualification and Experience

We are looking for a candidate with a scientific degree and proven experience in managing national and/or EU regulatory processes and registration aspects of the drug development process. Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and stages of the product life cycle is highly desirable.

Key skills include knowledge of drug development practice rules, regulations, and guidelines, as well as the ability to develop and implement regulatory strategies and communicate complex information to various scientific audiences.



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