EU Regulatory Affairs Manager - Strategy & Submissions

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs to join our regulatory function in a hybrid work model.

You will shape EU regulatory strategy and lead submissions, agency queries, and maintenance activities across development programmes. The role requires an advanced scientific degree and at least two years of EU regulatory experience, with strong negotiation and communication skills to coordinate with agencies and cross-functional teams.

Qualifications

• Advanced degree in a scientific discipline.
• At least two years’ 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.
• Clear stakeholder negotiation and excellent written and verbal communication skills.
• European Medicines Agency experience, including scientific advice, orphan designation, or paediatric investigation 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.
• You champion innovative EU pathways and share expertise across global regulatory and development teams.

Skills

Regulatory affairs

EU regulatory

Agency meetings

Stakeholder management

Clinical development

Education

Advanced degree in science

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs to join our regulatory function in a hybrid work model.

You will shape EU regulatory strategy and lead submissions, agency queries, and maintenance activities across development programmes. The role requires an advanced scientific degree and at least two years of EU regulatory experience, with strong negotiation and communication skills to coordinate with agencies and cross-functional teams.