Manager Regulatory Affairs

Regeneron Pharmaceuticals, Inc.; Uxbridge; Híbrido; GBP 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension benefits

Health and wellness programs

Paid time off

Descripción de la vacante

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.

Formación

• 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.

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 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.

Conocimientos

Regulatory affairs

EU regulatory

Agency meetings

Stakeholder management

Clinical development

Educación

Advanced degree in science

Descripción del empleo

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.

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

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.

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
• 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.

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.