Sr Dir CMC Regulatory Affairs

About the Role

We are looking for a leader to guide our CMC & Combination Products regulatory team, supporting a global portfolio of drug and device products with a strong focus on the European Union.

In this role, we work closely across functions to shape clear regulatory strategies that support development and keep submissions moving forward. You'll play a central role in connecting teams, guiding decisions, and ensuring global regulatory alignment.

Typical Day

• Lead a team delivering CMC and combination product regulatory activities
• Shape global regulatory strategies, with focus on EU requirements
• Advise senior leaders on regulatory direction and key considerations
• Oversee submissions and resolve complex compliance issues
• Work closely with regulators, partners, and external organisations
• Monitor new regulations and assess impact on the portfolio
• Improve processes and identify more efficient ways of working
• Support team development through coaching and regular feedback

Role May Be For You If You

• Enjoy leading teams and helping others grow in their roles
• Like setting direction while staying close to the detail
• Are comfortable working with senior stakeholders across functions
• Prefer a mix of strategic thinking and hands on problem solving
• Build strong, steady relationships with external partners and regulators
• Stay organised when handling multiple priorities at once
• Look for practical, simple ways to improve how work gets done
• Value clear, direct communication and keeping people aligned

Qualifications

• Substantial experience in regulatory affairs with a focus on CMC and/or combination products, including developing and guiding global regulatory strategies
• Bachelor's degree required; an advanced degree strongly preferred
• Experience leading teams, working with senior stakeholders, and a strong understanding of EU regulatory requirements
• Experience supporting global submissions is essential

Benefits

Comprehensive benefits vary by location.

Equal Opportunity Employer

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality or ethnic origin, civil status, age, citizenship status, membership in the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. Reasonable accommodation will be provided for applicants with known disabilities or chronic illnesses unless it causes undue hardship.