Europe Regulatory Strategist

Pfizer; Reigate and Banstead; Vor Ort; GBP 70.000 - 100.000; Vollzeit

Zusammenfassung

Pfizer seeks a seasoned Regulatory Leader to own regional regulatory strategies, interfacing with Health Authorities and cross-functional teams. You will drive submissions, labeling strategy, and regulatory risk plans across designated regions, ensuring alignment with global strategies and commercial goals.

The role requires proven experience in national/regional regulatory processes, strong stakeholder communication, and ability to influence regulators and senior leadership in a fast-paced

Qualifikationen

• Proven experience in managing national and/or regional regulatory processes for drug development, including clinical trials.
• Experience leading regulatory liaison activities for products across therapeutic areas.
• Strong knowledge of FDA/EMA/UK-HTA processes and global regulatory requirements.
• Ability to translate regulatory strategy into actionable plans for cross-functional teams.
• Excellent communication, negotiation, and presentation skills with senior stakeholders.

Aufgaben

• Represent a region for regulatory sciences (US, EU or EM) and align with Global Regulatory Strategy.
• Lead regional regulatory strategies with key stakeholders to support commercial goals.
• Ensure timely submissions and approvals with strategically favorable labeling.
• Maintain optimal interactions with Health Authorities for assigned projects.
• Contribute to Global Regulatory Strategies and implementation plans across regions.

Kenntnisse

Regulatory strategy

Regulatory liaison

Cross-functional leadership

Communication & presentation

Negotiation

Project management

Ausbildung

Scientific degree

Tools

RIM systems

Jobbeschreibung

Use Your Power for Purpose

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.

What You Will Achieve

• 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.

Here Is What You Need

• 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 agency(-ies) for US and EU regulatory strategists respectively, as well as participating in/leading such interactions, is preferred.
• Knowledge of drug development practice rules, regulations and guidelines - Familiarity with f actors likely to influence the regulatory environment, including new and emerging guidelines.
• Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations.
• Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
• Presentation skills - Is effective in a variety of formal presentation settings; one- on-one, small and large groups, with peers, direct reports and senior manager.
• Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.

Bonus Points If You Have

• Familiarity with electronic submission processes and regulatory information management systems
• Ability to work effectively in a fast-paced, dynamic environment
• Strong interpersonal skills and the ability to work collaboratively with cross-functional teams
• Excellent organizational and time management skills
• Ability to adapt to changing priorities and manage multiple tasks simultaneouslyStrong analytical skills and the ability to interpret