Manager Regulatory Affairs

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 80,000 - 110,000; Full time

Job summary

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

Qualifications

• 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.

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 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.

Skills

Stakeholder negotiation

Written & verbal comms

EU regulatory experience

Regulatory agency meetings

Education

Advanced degree in a scientific discipline

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Regulatory Affairs to join our regulatory function, supporting our European development programmes in a hybrid work model. In this role, you will shape EU regulatory strategy and support timely clinical development while collaborating with development teams, clinical teams, business partners, contract research organisations, and regulatory agencies. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.,

• 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.
• 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.
• Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If