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About the Role
Regeneron is seeking a Manager, Regulatory Affairs to join our regulatory function, supporting European development programmes in a hybrid work model. This role will shape EU regulatory strategy and support timely clinical development while collaborating with various teams and agencies.
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.
Requirements
- 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.
Skills
- European Medicines Agency experience, including scientific advice, orphan designation, or paediatric investigation plans, is advantageous.
Location
- Hybrid
Work Type
- Hybrid
Experience Level
- Manager
Education Level
- Advanced degree in a scientific discipline
Benefits
- 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
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Equal Opportunity
- 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.