Director of Operations, CMC Regulatory Sciences

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 Director to join our Regulatory Sciences team, to turn strategy into execution. Someone who is operationally minded, enjoys building and improving processes, develops high‑performing teams, and isn’t afraid to roll up their sleeves to remove roadblocks and drive results.

Location & Schedule

Location: Troy, New York, United States

Work model: Monday – Friday 8 am – 4:30 pm

Responsibilities

• Lead and manage a team responsible for authoring and coordinating CMC regulatory submissions across all modalities (biologics, small molecule, cell and gene therapy, and combination products) from IND/CTA through NDA/BLA and post‑approval lifecycle.
• Develop and implement global CMC regulatory strategies for product development and lifecycle management, aligning with business objectives and accelerating time to approval.
• Build and continuously improve team processes, templates, workflows, and submission tracking systems to increase throughput and consistency, enabling the team to reliably meet aggressive and shifting timelines.
• Establish and track operational metrics such as cycle time, submission quality, and on‑time delivery to identify bottlenecks and drive measurable improvements in team efficiency.
• Manage team capacity and workload distribution across concurrent submissions, proactively identifying resourcing gaps and reallocating support during peak submission periods.
• Mentor, coach, and develop staff to build bench strength and technical capability; represent the company in industry professional associations to help shape the external regulatory environment.
• Demonstrated experience managing or leading a team with a track record of developing talent and scaling team output.
• Strong working knowledge of FDA, EMA, and international CMC regulations and guidance across multiple modalities.

Qualifications

• BS/BA in a life sciences discipline (required).
• Associate Director: 10 + years of experience in the healthcare or biotech industry.
• Director: 12 + years of experience in the healthcare or biotech industry.
• Senior Director: 15 + years of experience in the healthcare or biotech industry.
• May consider an equivalent combination of education and experience; level is determined based on qualifications relevant to the role.
• Strong working knowledge of FDA, EMA, and international CMC regulations and guidance across multiple modalities.

Benefits

• Competitive total rewards package.
• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits, including 401(k) company match.
• Health and wellness programs and fitness centers.
• Insurance benefits (medical, dental, vision, life, and disability).
• Paid time off.
• Family support benefits.

Pay

Salary range (annually): $147,800 – $338,400.