Europe Regulatory Strategist in Guildford, Surrey

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.
• Ensure optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.
• Ensure 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, maximising 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 mitigated.
• Ensure an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s.
• Engage in appropriate activities 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 constructive working relationships 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.
• 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.
• Proven ability in developing and implementing regulatory strategy.
• 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.
• Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups.

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 organisational and time management skills.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• Strong analytical skills and the ability to interpret complex regulatory guidelines and requirements.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot.

Work Location Assignment: Hybrid (some office presence is required).

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms.

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career.