Senior Associate, Early Phase Oncology Regulatory Expert

3 settimane fa

Milano, Lombardia, Italia Pfizer A tempo pieno

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Early Phase Oncology department.

As a key member of our Global Regulatory Strategic Team, you will be responsible for representing the EU region in regulatory sciences and providing strategic expertise to support the development of our early-stage oncology portfolio.

Your primary focus will be on leading and implementing EU regulatory strategies, ensuring timely submissions and approvals, and maintaining optimal regulatory interactions with Health Authorities.

Job Responsibilities

  • Develop and implement EU regulatory strategies to support the early-stage oncology portfolio, ensuring alignment with company goals and objectives.
  • Collaborate with project teams to ensure required regulatory contributions meet business needs and are provided to the project teams in a timely and high-quality manner.
  • Monitor and communicate regulatory plan progress and variance to GRL and Senior Management, mitigating risks and ensuring regulatory compliance.
  • Engage with Health Authority contacts in the EU region to influence the regulatory environment and champion EU regulatory positions.
  • Develop and maintain constructive working relationships with Health Authority contacts and other stakeholders.

Qualifications

  • Scientific degree with a higher degree preferred.
  • Proven experience in managing national and/or EU regulatory processes and registration aspects of the drug development process, particularly clinical trials experience.
  • 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.
  • Excellent communication and negotiation skills, with the ability to communicate complex information to various scientific audiences.
  • Experience preparing and submitting CTAs, with knowledge of drug development practice rules, regulations, and guidelines.

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