Europe Regulatory Strategist

Pfizer Inc.; Knaphill; On-site; GBP 65,000 - 95,000; Full time

Job summary

Pfizer Inc. is seeking a regulatory professional to shape regional strategies for regulatory sciences and drive timely submissions across US, EU, or EM markets.

You will collaborate with the Global Regulatory Strategic Team to align regulatory plans with commercial goals and lead interactions with Health Authorities. Applicants should bring proven experience in managing regional regulatory processes, with strong communication and negotiation skills, and a solid understanding of drug development

Qualifications

• Scientific degree; higher degree preferred but not required.
• Experience managing national/regional regulatory processes (clinical trials).
• Regulatory liaison for at least one product across therapeutic areas.
• Familiar with FDA and major EU agencies; able to lead interactions.
• Strong communication and presentation skills for diverse audiences.
• Excellent negotiation with internal and external stakeholders.
• Knowledge of drug development regulations and guidelines.
• Ability to convey complex information clearly to varied audiences.

Responsibilities

• Represent regional regulatory strategies within GRST and align with commercial goals.
• Lead and implement regional regulatory plans; ensure timely submissions and approvals.
• Facilitate regulatory interactions with Health Authorities for assigned projects.
• Contribute to Global Regulatory Strategies and implementation plans.
• Monitor regulatory plans and report progress to Global Regulatory Lead and senior management.
• Engage with agencies and colleagues to influence regional regulatory environment.
• Champion compliance with regulatory standards across regions.
• Build strong relationships with Health Authority contacts in the region.

Skills

Regulatory operations experience

Regulatory liaison

FDA/EU agency familiarity

Stakeholder communication

Presentation skills

Negotiation skills

Regulatory guidelines knowledge

AI tools familiarity

Education

Scientific degree

Tools

AI tools familiarity

Job description

Use Your Power for PurposeAt Pfizer, we are on a mission to deliver medicines to the world with unparalleled speed, while upholding our commitment to excellence and integrity. Navigating the intricate web of local and global regulations is essential, and we need innovative thinkers like you to help us thrive in this dynamic landscape. Your expertise and dedication will be crucial in expanding and accelerating patient access to our life-changing medicines and vaccines.

What You Will Achieve

In this exciting role, you will:

• Represent a specific region for regulatory sciences (US, EU, or EM).
• Provide regional strategic expertise as a valued member of the Global Regulatory Strategic Team (GRST).
• Lead and implement regional regulatory strategies in collaboration with key stakeholders, aligning with commercial goals.
• Ensure timely submissions and approvals with commercially appealing labeling in your designated region.
• Facilitate optimal regulatory interactions with Health Authorities for assigned projects.
• Contribute to Global Regulatory Strategies and implementation plans for your projects.
• Monitor regulatory plans and communicate progress to the Global Regulatory Lead and Senior Management.
• Engage in activities to influence the regional regulatory environment through collaboration with colleagues and agencies.
• Champion business compliance and adherence to regulatory standards.
• Build constructive relationships with Health Authority contacts in your region.

A scientific degree; a higher degree is a plus but not mandatory.

• Proven experience in managing national and/or regional regulatory processes, particularly in clinical trials.
• Experience as a regulatory liaison for at least one product across various therapeutic areas and stages of the product life cycle.
• Familiarity with FDA or major EU regulatory agencies and experience in leading interactions with them.
• Knowledge of drug development regulations and guidelines, including emerging factors influencing the regulatory environment.
• Strong communication skills to convey complex information effectively to diverse audiences.
• Effective presentation skills for various settings, from one-on-one to large groups.
• Negotiation skills to navigate tough situations with internal and external stakeholders.

Bonus Points

• If You Have Familiarity with electronic submission processes and regulatory information management systems.
• Ability to thrive in a fast-paced, dynamic environment.
• Strong interpersonal skills for collaborative teamwork.
• Excellent organizational and time management abilities.
• Adaptability to changing priorities and multitasking.
• Strong analytical skills to interpret complex regulatory guidelines.
• Experience with AI tools, including generative technologies, to enhance productivity and problem-solving.

Purpose

At Pfizer, we are dedicated to breakthroughs that change patients' lives. Guided by our core values of courage, joy, equity, and excellence, we strive to transform millions of lives through our breakthrough culture.

Digital Transformation Strategy

We are leading the charge in digital transformation, adopting innovative data, modeling, and automated solutions to accelerate drug discovery and development, ultimately enhancing health outcomes and the patient experience.

Flexibility

We foster a trusting and flexible workplace culture that encourages work-life harmony, attracts top talent, and empowers everyone to be their best selves.

Equal Employment OpportunityWe believe that a diverse and inclusive workforce is vital to our success. Pfizer is committed to celebrating diversity in all its forms, allowing us to reflect the patients and communities we serve. Together, we build a culture that supports and empowers our employees.

DisAbility ConfidentAs a proud Disability Confident Employer, we encourage you to present your best self, knowing we will make any necessary adjustments to support your application and career. 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.