Europe Regulatory Strategist: Drive Regional Strategy & Submissions

Pfizer Inc.; Guildford; On-site; GBP 70,000 - 100,000; Full time

Job summary

Pfizer Inc. is seeking a Regulatory Affairs professional to lead regional regulatory strategies across the US, EU, or EM and ensure timely submissions in your region. You will collaborate with the Global Regulatory Strategic Team to align with commercial goals and enable faster patient access.

We value a scientific background, experience navigating FDA/EU agencies, strong communication and negotiation skills, and the ability to guide cross-functional teams through complex regulatory environments.

Qualifications

• Scientific degree required; higher degree advantageous.
• Proven experience in managing national/regional regulatory processes, including clinical trials.
• Regulatory liaison experience for at least one product across multiple therapeutic areas.
• Familiarity with FDA or major EU regulatory agencies; experience leading interactions.
• Knowledge of drug development regulations and guidelines including emerging factors.
• Strong communication and presentation skills; able to negotiate with stakeholders.

Responsibilities

• Represent a specific region for regulatory sciences (US, EU, or EM).
• Provide regional strategic expertise within the Global Regulatory Strategic Team (GRST).
• Lead regional regulatory strategies in collaboration with stakeholders.
• Ensure timely submissions and approvals with commercially aligned labeling.
• 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.

Skills

Regulatory experience

FDA/EU agency interactions

Drug development regulations

Regulatory liaison

Communication skills

Presentation skills

Negotiation skills

Education

Scientific degree

Higher degree (bonus)

Tools

Regulatory information systems

Job description

Pfizer Inc. is seeking a Regulatory Affairs professional to lead regional regulatory strategies across the US, EU, or EM and ensure timely submissions in your region. You will collaborate with the Global Regulatory Strategic Team to align with commercial goals and enable faster patient access.

We value a scientific background, experience navigating FDA/EU agencies, strong communication and negotiation skills, and the ability to guide cross-functional teams through complex regulatory environments.