Regulatory Affairs Manager

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 Regulatory Affairs Manager to join our EU team, supporting our development programmes in a hybrid work mode. In this role, you will shape EU regulatory strategies while collaborating with development teams, agencies, contract research organisations, and alliance partners. 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 role (Hybrid)

Discover your role:

• Develop EU-appropriate strategies using innovative regulatory pathways.
• Guide multidisciplinary study teams on EU requirements and global regulatory strategy.
• Lead study start-up, submissions, agency responses, compliance, and maintenance activities.
• Own Clinical Trial Applications through the Clinical Trials Information System across multiple EU member states.
• Manage amendments, annual reports, regulatory correspondence, and marketing authorisation application activities.
• Direct early and late-stage regulatory strategy to support timely end-to-end study conduct.
• Represent EU Regulatory Affairs with agencies, contract research organisations, and alliance partners.
• You monitor emerging EU legislation and promote company awareness and compliance.

This role requires:

• Advanced degree in a scientific discipline.
• At least two years’ regulatory experience supporting clinical development.
• Proven EU Clinical Trial Application approval and study start-up experience.
• Clear negotiation and communication with stakeholders at all levels.
• Direct national agency experience and face-to-face meeting leadership is advantageous.
• European Medicines Agency experience, including scientific advice, orphan designation, or paediatric investigation plans, is advantageous

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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, 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 you have any questions, please speak with your recruiter. 

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

Salary Range (annually)

€74,000.00 - €120,700.00