Europe Regulatory Strategist: Regional Strategy Submissions

Pfizer Inc.

Knaphill

On-site

GBP 65,000 - 95,000

Full time

2 days ago
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Job summary

Pfizer Inc. is seeking a regulatory professional to shape regional strategies for regulatory sciences and drive timely submissions across US, EU, or EM markets.

You will collaborate with the Global Regulatory Strategic Team to align regulatory plans with commercial goals and lead interactions with Health Authorities. Applicants should bring proven experience in managing regional regulatory processes, with strong communication and negotiation skills, and a solid understanding of drug development

Qualifications

  • Scientific degree; higher degree preferred but not required.
  • Experience managing national/regional regulatory processes (clinical trials).
  • Regulatory liaison for at least one product across therapeutic areas.
  • Familiar with FDA and major EU agencies; able to lead interactions.
  • Strong communication and presentation skills for diverse audiences.
  • Excellent negotiation with internal and external stakeholders.
  • Knowledge of drug development regulations and guidelines.
  • Ability to convey complex information clearly to varied audiences.

Responsibilities

  • Represent regional regulatory strategies within GRST and align with commercial goals.
  • Lead and implement regional regulatory plans; ensure timely submissions and approvals.
  • Facilitate regulatory interactions with Health Authorities for assigned projects.
  • Contribute to Global Regulatory Strategies and implementation plans.
  • Monitor regulatory plans and report progress to Global Regulatory Lead and senior management.
  • Engage with agencies and colleagues to influence regional regulatory environment.
  • Champion compliance with regulatory standards across regions.
  • Build strong relationships with Health Authority contacts in the region.

Skills

Regulatory operations experience
Regulatory liaison
FDA/EU agency familiarity
Stakeholder communication
Presentation skills
Negotiation skills
Regulatory guidelines knowledge
AI tools familiarity

Education

Scientific degree

Tools

AI tools familiarity

Job description

Pfizer Inc. is seeking a regulatory professional to shape regional strategies for regulatory sciences and drive timely submissions across US, EU, or EM markets.

You will collaborate with the Global Regulatory Strategic Team to align regulatory plans with commercial goals and lead interactions with Health Authorities. Applicants should bring proven experience in managing regional regulatory processes, with strong communication and negotiation skills, and a solid understanding of drug development

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