Europe Regulatory Strategy Lead (Hybrid)

Pfizer Inc; Guildford; Hybrid; GBP 85,000 - 120,000; Full time

Job summary

Pfizer in the United Kingdom seeks a Senior Regulatory Scientist to drive regional regulatory strategies across US, EU, or EM markets. You will join the Global Regulatory Strategic Team and lead submissions with the aim of rapid approvals and commercially aligned labeling.

You will manage Health Authority interactions, coordinate cross-functional teams, and ensure plans meet time and quality standards while mitigating risks. Hybrid work arrangements apply in the Guildford area.

Qualifications

• Scientific degree; a higher degree may be an advantage.
• Proven experience managing national/regional regulatory processes for drug development.
• Experience as regulatory liaison with FDA/EMA for US/EU strategies.
• Experience preparing and submitting INDs/CTAs, NDAs/MAA/IRDs.
• Strong communication and presentation skills with senior management.
• Negotiation skills and ability to influence regulators and stakeholders.

Responsibilities

• Represent regional regulatory science for US, EU or EM.
• Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
• Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
• Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region.
• Be accountable for ensuring optimal regulatory interactions with Health Authorities in the assigned region.
• Be accountable for ensuring regional (US, EU or EM) contributions to Global Regulatory Strategies and implementation plans.
• Ensure regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and risks mitigated.
• Engage with project teams to ensure required regulatory contributions meet business needs and are provided on time and to quality standards.

Skills

Regulatory strategy

Stakeholder management

FDA/EMA liaison

Communication skills

Presentation skills

Negotiation skills

Regulatory intelligence

Education

Scientific degree

Tools

Regulatory submission tools

Job description

Pfizer in the United Kingdom seeks a Senior Regulatory Scientist to drive regional regulatory strategies across US, EU, or EM markets. You will join the Global Regulatory Strategic Team and lead submissions with the aim of rapid approvals and commercially aligned labeling.

You will manage Health Authority interactions, coordinate cross-functional teams, and ensure plans meet time and quality standards while mitigating risks. Hybrid work arrangements apply in the Guildford area.