EU Regulatory Strategy Lead

Pfizer Inc; Woking; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Pfizer is seeking a Regulatory Affairs professional to drive regional strategies, liaise with global teams, and lead submissions across the US/EU/EM regions. You’ll ensure timely approvals, manage health authority interactions, and contribute to core labeling plans within a collaborative, matrix environment.

The role requires strong communication, negotiation, and presentation skills, with experience in regulatory submissions and cross-functional teams in the pharma sector.

Qualifications

• Scientific degree required.
• Higher degree preferred.
• Experience with national/regional regulatory submissions.
• Regulatory liaison experience across products/therapies.
• Experience with FDA/EU agencies.
• Knowledge of drug development regulations.
• Track record in regulatory strategy development.
• Strong communication skills.
• Effective presentation skills.
• Negotiation skills.

Responsibilities

• Represent regional regulatory strategy as GRST member.
• Lead regional regulatory strategies with stakeholders.
• Ensure timely submissions and approvals with acceptable labeling.
• Manage regulatory interactions with Health Authorities.
• Contribute to Global Regulatory Strategies and core labels.
• Monitor plans and mitigate risks with management.
• Engage with regulators and industry groups as appropriate.

Skills

Regulatory strategy

Stakeholder management

Regulatory submissions

FDA / EU experience

Communication skills

Leadership

Negotiation

Education

Scientific Degree

Advanced degree advantageous

Tools

Regulatory IT systems

eCTD submissions

Job description

Pfizer is seeking a Regulatory Affairs professional to drive regional strategies, liaise with global teams, and lead submissions across the US/EU/EM regions. You’ll ensure timely approvals, manage health authority interactions, and contribute to core labeling plans within a collaborative, matrix environment.

The role requires strong communication, negotiation, and presentation skills, with experience in regulatory submissions and cross-functional teams in the pharma sector.