European Regulatory Strategist: Lead Submissions & Strategy

Pfizer Inc; Kempton Park; Hybrid; GBP 70,000 - 120,000; Full time

Job summary

Pfizer, a global leader in medicines and vaccines, seeks a Regulatory Affairs professional in the United Kingdom. You will represent a region for regulatory sciences, lead regional strategies, and partner with project teams to align with commercial goals.

You will drive timely submissions, manage Health Authority interactions, and contribute to Global Regulatory Strategies across US/EU/EM regions, ensuring compliant labelling and optimal project delivery.

Qualifications

• Proven experience managing national/regional regulatory processes for drug development.
• Experience with INDs, CTAs, MAAs/IRDs across regions.
• Strong communication and negotiation skills with regulators.
• Ability to work with cross-functional teams across functions.

Responsibilities

• Represent a region for regulatory sciences (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 relation to the assigned project(s) within the designated region.
• Be accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
• Ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities.
• Partner with project teams and other customer groups to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time and quality standards.
• Ensure regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks mitigated.
• Ensure an aligned regional regulatory position is reached and communicated for all key issues for assigned project(s), and that these regulatory positions supporting the regional business are championed and communicated.
• Engage in appropriate activities to influence the regional regulatory environment through in-country colleagues, Agency contacts, and Trade Associations as appropriate.
• Ensure business compliance and implementation of and adherence to Regulatory standards.
• Develop and maintain, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.

Skills

Regulatory strategy development

Regulatory submissions

FDA/EMA interactions

Stakeholder management

Communication skills

Presentation skills

Education

Scientific Degree

Tools

Regulatory information management systems

Job description

Pfizer, a global leader in medicines and vaccines, seeks a Regulatory Affairs professional in the United Kingdom. You will represent a region for regulatory sciences, lead regional strategies, and partner with project teams to align with commercial goals.

You will drive timely submissions, manage Health Authority interactions, and contribute to Global Regulatory Strategies across US/EU/EM regions, ensuring compliant labelling and optimal project delivery.