Senior Associate, Early Phase, Regulatory Affairs

1 mese fa

Milano, Italia Pfizer, S.A. de C.V A tempo pieno

Senior Associate, Early Phase, Regulatory Affairs

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Key Responsibilities:

  • 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.
  • Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans for assigned early-stage oncology portfolio.
  • Ensure regulatory contributions achieve the objectives in the strategy, maximizing overall project delivery time and probability of success.
  • Partner with project teams to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time and quality standards.
  • Monitor regulatory plans, communicate progress/variance to GRL and Senior Management, and mitigate any risks.
  • Ensure an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s.
  • Engage in activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.
  • Ensure business compliance and implementation of and adherence to Regulatory standards.
  • Develop and maintain 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 members.
  • Partners with EU colleagues, including GRS-in Country colleagues and Medical colleagues.
  • Works directly or indirectly with external contacts in Regulatory Agencies within the EU region.
  • Ensures alignment with GRL and early phase Oncology Global Head.

Minimum Requirements:

  • 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 stages of the product life cycle is highly desirable.
  • Experience in communicating with major EU regulatory agencies 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.
  • Strong communication skills to convey complex information to a variety of scientific audiences.
  • Effective presentation skills in various formal settings.
  • Negotiation skills to navigate tough situations with internal and external groups.

Purpose:

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

Flexibility:

We aim to create a trusting, flexible workplace culture that encourages employees to achieve work-life harmony. Let’s start the conversation

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.

Disability Inclusion:
Our mission is unleashing the power of all our people, and we are proud to be a disability-inclusive employer, ensuring equal employment opportunities for all candidates.

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