Europe Regulatory Strategist

We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.

We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.

In this role, you will:

• Represent a particular 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 (line plans, label, CTA, MAA/IRD, variations, license renewals etc.) 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 (from emerging technical data, changing internal objectives or external threats) 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 in order to influence the regional regulatory environment through OGRS-In Country colleagues, Agency contacts, and/or 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.

• Scientific Degree. A higher degree may be an advantage but is not essential.
• Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country.
• Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry - government collaborations, can be considered.
• Experience in communicating with FDA or major EU regulatory…