Manager Regulatory Affairs

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

Build our future together: 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.

When & where: Multiple locations are being considered for this position (Hybrid)

Discover your role:

• 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.

This role requires:

• 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.

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
• family support benefits

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.