Senior Associate, Early Phase, Regulatory Affairs

1 mese fa

Milano, Italia Pfizer A tempo pieno

Senior Associate, Early Phase, Regulatory Affairs

Job Summary

  • Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio
  • Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST)
  • Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals
  • Accountable for timely submissions and approvals in the EU region
  • Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU

Job Responsibilities

  • Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolio
  • Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating submission activities
  • Partners with project teams to ensure required regulatory contributions (CTA, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards
  • Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks mitigated
  • Ensures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s
  • Engages in appropriate activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate
  • Ensures business compliance and implementation of and adherence to Regulatory standards
  • Develops and maintains constructive working relationships with Health Authority contacts in the EU region

Organizational Relationship

  • Reports to early phase Oncology EU lead
  • Works with GRS colleagues and relevant project team(s) members
  • Partners with EU colleagues, including GRS-in Country colleagues and Medical colleagues
  • Works directly or indirectly with external contacts in Regulatory Agencies within EU region
  • Ensures alignment with GRL and early phase Oncology Global Head

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
  • 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
  • Experience in communicating with major EU regulatory agency(ies) and participating in/leading such interactions is preferred
  • Knowledge of drug development practice rules, regulations and guidelines
  • Proven ability in developing and implementing regulatory strategy
  • Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences
  • Presentation skills - Effective in various formal presentation settings
  • Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups

About Us

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare and the potential to transform millions of lives. We’re looking for new talent to join our global community to unearth innovative therapies that make the world a healthier place.

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