Manager Regulatory Affairs (EU)

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 Affairs function, supporting our EU and international markets in a hybrid work mode. In this role, you will lead regulatory activities and strategies across oncology and rare diseases while collaborating with global teams, local entities, and business partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: Amsterdam (Hybrid) Discover your role: - Manage regulatory activities for assigned products across EU and international markets. - Coordinate global teams, local entities, and partners across clinical, labelling, commercial, and quality functions. - Communicate evolving regulatory strategies and insights across in-scope markets. - Develop processes, user guides, work instructions, and standard operating procedures. - Represent Regulatory Affairs in cross-functional forums and negotiate regulatory objectives. - Support inspections and EU and UK Clinical Trial Applications when required. - Ensure activities follow procedures and company standards. - You foster effective matrix working while adapting to changing priorities. This role requires: - Bachelor’s or advanced degree in life sciences, pharmacy, or a related scientific discipline. - Three to four years’ biopharmaceutical regulatory affairs experience. - Regulatory requirements knowledge and proficiency with regulatory databases. - Ability to manage parallel submissions against firm deadlines. - Strong written communication, project management, and problem-solving skills. - Matrix working experience in a global environment. - Approved-product regulatory leadership with local affiliates is advantageous. - Chemistry, Manufacturing and Controls knowledge covering biologics and clinical requirements is advantageous. - Oncology or rare disease experience is preferred. 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.