Regulatory Affairs Specialist, Early Phase Oncology

2 settimane fa

Milano, Lombardia, Italia Pfizer A tempo pieno

Job Summary

As a key member of our Global Regulatory Strategic Team, you will represent the EU region for regulatory sciences in relation to our designated early-stage oncology portfolio. Your expertise will be instrumental in providing regional strategic guidance and leading EU regulatory strategies for assigned projects and products.

Key Responsibilities

  • Develop and implement EU regulatory strategies in agreement with key stakeholders, ensuring timely submissions and approvals in the EU region.
  • Collaborate with project teams to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time and quality standards.
  • Ensure regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks mitigated.
  • Engage in appropriate activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.

Organizational Relationship

You will report to the early phase Oncology EU lead and work closely with GRS colleagues and relevant project team members. Your role will also involve partnering with EU colleagues, including GRS-in Country colleagues and Medical colleagues, to provide an EU position.

Qualification Skills

  • Scientific Degree. A higher degree may be an advantage but is not essential.
  • Proven experience in managing national and/or EU regulatory process and registration aspects of the drug development process, particularly clinical trials experience at least in one country.
  • Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable.

Purpose

At Pfizer, we are a patient-centric company guided by our four values: courage, joy, equity, and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

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