Europe Regulatory Strategist

Pfizer Inc.; Guildford; On-site; GBP 70,000 - 100,000; Full time

Job summary

Pfizer Inc. is seeking a Regulatory Affairs professional to lead regional regulatory strategies across the US, EU, or EM and ensure timely submissions in your region. You will collaborate with the Global Regulatory Strategic Team to align with commercial goals and enable faster patient access.

We value a scientific background, experience navigating FDA/EU agencies, strong communication and negotiation skills, and the ability to guide cross-functional teams through complex regulatory environments.

Qualifications

• Scientific degree required; higher degree advantageous.
• Proven experience in managing national/regional regulatory processes, including clinical trials.
• Regulatory liaison experience for at least one product across multiple therapeutic areas.
• Familiarity with FDA or major EU regulatory agencies; experience leading interactions.
• Knowledge of drug development regulations and guidelines including emerging factors.
• Strong communication and presentation skills; able to negotiate with stakeholders.

Responsibilities

• Represent a specific region for regulatory sciences (US, EU, or EM).
• Provide regional strategic expertise within the Global Regulatory Strategic Team (GRST).
• Lead regional regulatory strategies in collaboration with stakeholders.
• Ensure timely submissions and approvals with commercially aligned labeling.
• 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.

Skills

Regulatory experience

FDA/EU agency interactions

Drug development regulations

Regulatory liaison

Communication skills

Presentation skills

Negotiation skills

Education

Scientific degree

Higher degree (bonus)

Tools

Regulatory information systems

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.

Qualifications

• 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

• 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. Let's start the conversation!

Equal Employment Opportunity

We 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 Confident

As 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.

Join Our Regulatory Affairs Team!Are you ready to make a difference? We can't wait to see how you can contribute to our mission!