EU Regulatory Affairs Manager – Hybrid Strategy Submissions

Regeneron Pharmaceuticals, Inc.; Uxbridge; Híbrido; GBP 80.000 - 110.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Manager of Regulatory Affairs to shape EU regulatory strategy and support European development programs in a hybrid model.

You will coordinate with development teams, clinical teams, business partners, CROs and agencies to advance timely clinical development and maintain regulatory compliance. You will lead EU submissions, respond to agency queries, and oversee start-up and ongoing activities across programs, advocating innovative EU pathways and

Formación

• Must have strong negotiation and communication skills.
• Experience across clinical development and post-approval activities.
• Experience supporting EU Clinical Trial Applications through approval and start-up.
• European Medicines Agency experience advantageous.

Responsabilidades

• 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 CROs across late-stage studies.
• Support EU regulatory strategy alignment with business objectives.
• Monitor EU legislation and guidance to ensure compliance.
• Build relationships with EMA, national agencies and alliance partners.
• Lead early and late-stage regulatory strategy for timely study conduct.

Conocimientos

Stakeholder negotiation

Written & verbal comms

EU regulatory experience

Regulatory agency meetings

Educación

Advanced degree in a scientific discipline

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks a Manager of Regulatory Affairs to shape EU regulatory strategy and support European development programs in a hybrid model.

You will coordinate with development teams, clinical teams, business partners, CROs and agencies to advance timely clinical development and maintain regulatory compliance. You will lead EU submissions, respond to agency queries, and oversee start-up and ongoing activities across programs, advocating innovative EU pathways and