EU Regulatory Affairs Manager — Strategy & Submissions

Regeneron UK Limited; Uxbridge; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Regeneron UK Limited is seeking a Manager, Regulatory Affairs to shape EU regulatory strategy and support timely clinical development in a hybrid work model. You will collaborate with development, clinical, business, CROs, and regulators to drive compliant, patient-focused programs.

The role covers leading EU submissions, agency queries, start-up and maintenance activities, and regulatory strategy across late-stage studies.

Qualifications

• At least two years of regulatory experience across clinical development and post-approval activities.
• Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
• Direct experience with national regulatory agencies and leading face-to-face agency meetings.
• Excellent written and verbal communication; strong stakeholder negotiation.
• EMA experience (scientific advice, orphan designation, or paediatric plans) is advantageous.

Responsibilities

• Develop EU-appropriate regulatory strategies with development teams and regulatory management.
• Lead clinical study submissions, agency queries, compliance, start-up, and maintenance activities.
• Represent Regeneron with contract research organisations across complex late-stage clinical studies.
• Support business partners in aligning EU regulatory strategy with business objectives.
• Monitor emerging EU legislation and guidance, supporting company awareness and compliance.
• Build relationships with the European Medicines Agency, national agencies, and alliance partners.
• Lead early and late-stage regulatory strategy for timely end-to-end study conduct.
• Champion innovative EU pathways and share expertise across global regulatory and development teams.

Skills

Regulatory experience

EU regulatory submissions

Agency meetings

Stakeholder communication

Education

Advanced degree in a scientific discipline

Job description

Regeneron UK Limited is seeking a Manager, Regulatory Affairs to shape EU regulatory strategy and support timely clinical development in a hybrid work model. You will collaborate with development, clinical, business, CROs, and regulators to drive compliant, patient-focused programs.

The role covers leading EU submissions, agency queries, start-up and maintenance activities, and regulatory strategy across late-stage studies.