Director, CMC Regulatory Sciences
About The Position
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, leading the development and execution of global CMC regulatory strategies across all Regeneron modalities and product lifecycle stages. In this role, you will oversee a team responsible for the quality, consistency, and timeliness of regulatory submissions — from first-in-human filings through post-approval maintenance — while collaborating with Manufacturing, Quality Control, Clinical, and Program Management teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Requirements
- BS/BA in a life sciences discipline required
- Director: 12+ years of experience in the healthcare or biotech industry
- 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
Nice To Haves
- Associate Director: 10+ years of experience in the healthcare or biotech industry
- Senior Director: 15+ years of experience in the healthcare or biotech industry
- May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role
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
- Direct the preparation, review, and submission of CMC documentation including product specifications, justification of specifications, and comparability assessments, ensuring scientific rigor and regulatory compliance
- 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
- Interact directly with regulatory authorities to represent CMC strategy and submission content; monitor regulatory intelligence and translate emerging trends into updated internal policies and procedures
- 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
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
