EU Regulatory Strategy Lead – Clinical Development

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybride; GBP 70 000 - 110 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals in the UK is seeking a Manager, Regulatory Affairs to join our regulatory function in a hybrid work model. You will shape EU regulatory strategy and support timely clinical development while collaborating with development teams, clinical teams, business partners, CROs, and regulatory agencies.

The role offers the chance to influence EU pathways, lead submissions, engage with the EMA and national agencies, and mentor teams across global regulatory and development

Qualifications

• Advanced degree in a scientific discipline.
• At least two years' regulatory experience across clinical development and post-approval activities.
• Experience supporting EU Clinical Trial Applications through approval and startup.
• Direct experience with national regulatory agencies and leading face-to-face agency meetings.
• Clear stakeholder negotiation and excellent written and verbal communication skills.
• EMA experience (scientific advice, orphan designation, or paediatric investigation plans) advantageous.

Responsabilités

• 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 EU legislation and guidance to ensure awareness and compliance.
• Build relationships with the European Medicines Agency and national agencies.
• Lead early and late-stage regulatory strategy for timely end-to-end study conduct.
• Champion innovative EU pathways and share expertise across global teams.

Connaissances

Regulatory experience

EU regulatory strategy

Agency meetings

Stakeholder communication

Formation

Advanced degree in a scientific discipline

Description du poste

Regeneron Pharmaceuticals in the UK is seeking a Manager, Regulatory Affairs to join our regulatory function in a hybrid work model. You will shape EU regulatory strategy and support timely clinical development while collaborating with development teams, clinical teams, business partners, CROs, and regulatory agencies.

The role offers the chance to influence EU pathways, lead submissions, engage with the EMA and national agencies, and mentor teams across global regulatory and development