Europe Regulatory Strategist

Pfizer; Tadworth; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Pfizer sucht eine erfahrene Regulatory Scientist für die Region UK, die als Teil des Global Regulatory Strategic Team (GRST) eine regionale Strategie entwickelt und umsetzt. Sie führen Registrierungen durch, koordinieren Behördengespräche und arbeiten eng mit Projektteams zusammen, um zeitnahe Genehmigungen und marktkonforme Kennzeichnungen sicherzustellen.

In dieser Rolle arbeiten Sie hybrid, arbeiten mit internationalen Behörden zusammen und tragen dazu bei, patientenzugang zu beschleunigen,

Qualifications

• Scientific degree in life sciences or related field.
• Experience in managing national/regional regulatory processes and registrations.
• Experience communicating with US/EU regulators for regulatory strategy.

Responsibilities

• Represent a regional regulatory voice (US, EU, or EM) for Pfizer products.
• Provide regional regulatory strategy aligned with Global Regulatory Strategy Team goals.
• Lead region-specific submissions and interactions with health authorities.
• Ensure timely submissions and appropriate labelling in the designated region.
• Collaborate with project teams to maintain core labels, variations, and renewals.
• Monitor progress, communicate risks, and mitigate regulatory hurdles.
• Develop and maintain relationships with health authority contacts in the region.

Skills

Regulatory strategy

Global/regional liaison

INDs/CTAs submissions

FDA/EU regulatory interactions

Stakeholder management

Regulatory submissions management

Regulatory guidelines knowledge

Risk assessment

Negotiation skills

Education

Scientific Degree in Life Sciences

Tools

eCTD submission tools

Regulatory information management systems

Job description

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

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.

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 systemsAbility to work effectively in a fast-paced, dynamic environmentStrong interpersonal skills and the ability to work collaboratively with cross-functional teamsExcellent organizational and time management skillsAbility to adapt to changing priorities and manage multiple tasks simultaneouslyStrong analytical skills and the ability to interpret complex regulatory guidelines and requirementsExperience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment

Hybrid (some office presence is required)

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are apatient 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.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy.

Flexibility

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.Let’s start the

conversation!

Equal Employment Opportunity

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 – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

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. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on

Pfizer Careers

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