Senior Regulatory Strategist — Medicines

Pfizer Inc; Reigate and Banstead; Vor Ort; GBP 60.000 - 90.000; Vollzeit

Zusammenfassung

Pfizer is seeking a Regulatory Affairs professional in the United Kingdom to lead strategic regulatory activities for assigned products and markets, ensuring timely Marketing Authorizations and alignment with clinical trials where applicable. You will collaborate with above-country hubs to implement regulatory strategies, maintain databases, and respond to NRA queries.

The role emphasizes cross-functional advisory, MA variations and renewals, and ongoing regulatory intelligence sharing to

Qualifikationen

• Life sciences or chemistry graduate to honors level or equivalent.
• Master’s degree, Post Graduate Diploma or PhD preferred.
• Relevant Professional Qualifications desirable, e.g. MSc in Regulatory.
• Previous experience in Regulatory (Human Medicinal Products) in UK & Ireland.
• Computer literacy with strong written and verbal communication.
• Analytical thinking and problem solving.

Aufgaben

• Deliver Regulatory Strategy and advise cross-functional teams.
• Manage New Registration/Marketing Authorization applications.
• Manage MA variation and renewal applications.
• Respond to NRA queries and provide regulatory intelligence.
• Support regulatory activities for medical devices if required.
• Populate and maintain regulatory databases.
• Support MA divestments, cancellations, and supply continuity.
• Contribute to Good Regulatory Practice and group development.

Kenntnisse

Regulatory Strategy

Cross-Functional Collaboration

Communication skills

Analytical thinking

Life sciences background

Ausbildung

Life sciences degree

Master's degree preferred

Tools

Microsoft Office

Regulatory databases

Jobbeschreibung

Pfizer is seeking a Regulatory Affairs professional in the United Kingdom to lead strategic regulatory activities for assigned products and markets, ensuring timely Marketing Authorizations and alignment with clinical trials where applicable. You will collaborate with above-country hubs to implement regulatory strategies, maintain databases, and respond to NRA queries.

The role emphasizes cross-functional advisory, MA variations and renewals, and ongoing regulatory intelligence sharing to