Regulatory Affairs Specialist

2 mesi fa

Milano, Lombardia, Italia Pfizer A tempo pieno
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Global Regulatory Sciences team, you will be responsible for representing the EU region in regulatory matters related to early-stage oncology portfolio.

Key Responsibilities
  • Develop and implement EU regulatory strategies in collaboration with key stakeholders to ensure timely submissions and approvals in the EU region.
  • Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) to ensure optimal regulatory interactions with Health Authorities.
  • Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals.
  • Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans for assigned early-stage oncology portfolio.
  • Ensure regulatory contributions meet business needs and are provided to project teams to agreed time and quality standards.
  • Communicate complex information and analyses to a variety of scientific audiences, including senior management.
  • Develop and maintain constructive working relationships with Health Authority contacts in the EU region.
Requirements
  • Scientific degree with a higher degree preferred but not essential.
  • Proven experience in managing national and/or EU regulatory process 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 in different stages of the product life cycle.
  • Experience in communicating with major EU regulatory agencies and participating in/leading such interactions.
  • Knowledge of drug development practice rules, regulations, and guidelines.
  • Proven ability in developing and implementing regulatory strategy.
About Pfizer

Pfizer is 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. We aim to create a trusting, flexible workplace culture which encourages employees to achieve work-life harmony, attracts talent, and enables everyone to be their best working self.

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating diversity in all its forms – allowing us to be as diverse as the patients and communities we serve.

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