Europe Regulatory Strategy Lead

Pfizer; United Kingdom; Hybrid; GBP 65,000 - 95,000; Full time

Job summary

Pfizer is seeking a regulatory science professional to lead regional regulatory strategies across US, EU or EM. You will coordinate with cross-functional teams to drive submissions, manage labels, and optimise regulatory interactions with Health Authorities.

You'll influence global/regional plans, monitor risks, and ensure alignment with business objectives across assigned projects, in a hybrid work environment.

Qualifications

• Scientific degree in a relevant field; higher degree is advantageous.
• Proven national/regional regulatory process and registration experience.
• Experience as regulatory liaison for products across therapeutic areas is desirable.
• Experience communicating with major regulatory agencies (FDA/EC) for US/EU strategies preferred.
• Ability to develop and implement regulatory strategy and manage submissions.

Responsibilities

• Represent a regional regulatory science lead for US, EU or EM.
• Lead and implement regional regulatory strategies with key stakeholders.
• Ensure timely submissions and approvals with compliant labelling.
• Drive regulatory interactions with Health Authorities and post-filing activities.
• Monitor plans, communicate risks, and align regional positions across projects.

Skills

Regulatory strategy

Regulatory liaison

Communication skills

Presentation skills

Negotiation

Cross-functional collaboration

Education

Scientific degree

Higher degree preferred

Tools

Regulatory information systems

IND/CTA submissions workflow

Job description

Pfizer is seeking a regulatory science professional to lead regional regulatory strategies across US, EU or EM. You will coordinate with cross-functional teams to drive submissions, manage labels, and optimise regulatory interactions with Health Authorities.

You'll influence global/regional plans, monitor risks, and ensure alignment with business objectives across assigned projects, in a hybrid work environment.