Europe Regulatory Strategy Lead

Pfizer Inc.; Shere; On-site; GBP 70,000 - 120,000; Full time

Job summary

Pfizer Inc. in the United Kingdom seeks a regional regulatory science leader to shape and execute regulatory strategies for US, EU or EM markets within the Global Regulatory Strategic Team.

You will partner with project teams to secure timely submissions, favourable labelling and robust Health Authority interactions. This role requires a scientific degree and proven experience in national/regional regulatory processes, INDs/CTAs, NDAs/MAA/IRDs, and successful collaboration with FDA and major EU

Qualifications

• Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process.
• Experience communicating with FDA or major EU regulatory agency(-ies) and leading such interactions.

Responsibilities

• Lead and implement regional regulatory strategies in agreement with stakeholders for assigned projects.
• Ensure timely submissions and approvals with commercially attractive labelling.
• Maintain constructive relationships with Health Authority contacts in the assigned region.
• Monitor regulatory plans and communicate risks and progress to Global Regulatory Lead.

Education

Scientific degree

Job description

Pfizer Inc. in the United Kingdom seeks a regional regulatory science leader to shape and execute regulatory strategies for US, EU or EM markets within the Global Regulatory Strategic Team.

You will partner with project teams to secure timely submissions, favourable labelling and robust Health Authority interactions. This role requires a scientific degree and proven experience in national/regional regulatory processes, INDs/CTAs, NDAs/MAA/IRDs, and successful collaboration with FDA and major EU