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    {"title": "Regulatory Affairs Specialist", "content": "Job SummaryPfizer is seeking a highly skilled Regulatory Affairs Specialist to join our Early Phase Oncology team. As a key member of our regulatory team, you will be responsible for ensuring EU regulatory compliance and contributing to the development of regulatory strategies for our early-stage...

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    {"Job Title": "Senior Associate, Early Phase, Regulatory Affairs", "Job Summary": "As a key member of our Global Regulatory Strategic Team, you will be responsible for representing the EU region in regulatory sciences related to our early-stage oncology portfolio. Your expertise will be crucial in providing regional strategic guidance and implementing EU...

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Senior Regulatory Associate, Early Stage Oncology

2 mesi fa

Milano, Lombardia, Italia Pfizer A tempo pieno

Position Overview

The successful candidate will represent the European region (EU, UK, CH, NZ, AUS) in regulatory sciences concerning the designated early-stage oncology portfolio. This role involves providing regional strategic insights as part of the Global Regulatory Strategic Team (GRST).

Key Responsibilities

  • Lead the formulation and execution of EU regulatory strategies in collaboration with key stakeholders, ensuring alignment with corporate objectives for assigned projects/products.
  • Ensure timely submissions and approvals within the EU region, maintaining accountability for regulatory interactions with Health Authorities related to the early-stage oncology portfolio.
  • Guarantee EU contributions to Global Regulatory Strategies and implementation plans, including core labels and risk registers for the assigned oncology portfolio.
  • Collaborate with project teams to ensure that necessary regulatory contributions (e.g., Clinical Trial Applications) are delivered to meet business requirements and quality standards.
  • Monitor regulatory plans, communicate progress and variances to the Global Regulatory Lead (GRL) and Senior Management, and address any risks arising from emerging data or external challenges.
  • Achieve consensus on EU regulatory positions for all significant issues pertaining to assigned projects, advocating for these positions to support the EU business.
  • Engage in initiatives to influence the EU regulatory landscape through collaboration with GRS-In Country colleagues, Agency contacts, and relevant Trade Associations.
  • Uphold business compliance and ensure adherence to regulatory standards.
  • Develop and nurture constructive relationships with Health Authority contacts across the EU region.

Reporting Structure

  • Reports directly to the early phase Oncology EU lead.
  • Collaborates with GRS colleagues and relevant project team members, including Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance, and Legal.
  • Partners with EU colleagues, including GRS-in Country and Medical teams, to present a unified EU position.
  • Engages with external contacts in Regulatory Agencies within the EU region.
  • Ensures alignment with the Global Regulatory Lead and the early phase Oncology Global Head.

Qualifications

  • A scientific degree is required; a higher degree is advantageous but not mandatory.
  • Demonstrated experience in managing national and/or EU regulatory processes and registration aspects of drug development, particularly in clinical trials.
  • Previous experience as a national and/or EU regulatory liaison for at least one product across various therapeutic areas and stages of the product lifecycle is highly desirable.
  • Experience in communicating with major EU regulatory agencies and leading such interactions is preferred.
  • Comprehensive knowledge of drug development practices, regulations, and guidelines, along with familiarity with factors influencing the regulatory environment.
  • Proven capability in developing and executing regulatory strategies, with an understanding of regulatory agency philosophies and guidelines.
  • Strong communication skills, with the ability to convey complex information to diverse scientific audiences in both verbal and written formats.
  • Effective presentation skills in various formal settings, whether one-on-one or in group scenarios.
  • Skilled negotiation abilities, capable of navigating challenging situations with both internal and external stakeholders.

Our Commitment

At Pfizer, we are dedicated to transforming patients' lives through our core values: courage, joy, equity, and excellence. Our culture fosters breakthroughs that change lives, and we are committed to a diverse and inclusive workforce that reflects the communities we serve.

Digital Transformation

We are advancing our digital transformation strategy to enhance drug discovery and development, aiming to improve health outcomes and the patient experience.

Workplace Flexibility

We strive to create a flexible workplace culture that promotes work-life harmony and empowers our employees to perform at their best.