Director of Operations, CMC Regulatory Sciences
Regeneron
August 11, 2026
On-site
Troy, NY
Operations
Role Responsibilities:
- Lead and manage a team responsible for authoring and coordinating CMC regulatory submissions across biologics, small molecule, cell/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.
- Establish and track operational metrics (cycle time, submission quality, on-time delivery) to identify bottlenecks and drive measurable efficiency improvements.
- Manage team capacity and workload distribution across concurrent submissions; identify resourcing gaps and reallocate support during peak periods.
- Mentor, coach, and develop staff; represent the company in industry professional associations to shape the external regulatory environment.
Qualifications/Requirements:
- BS/BA in a life sciences discipline (required).
- Associate Director: 10+ years in healthcare/biotech.
- Director: 12+ years in healthcare/biotech.
- Senior Director: 15+ years in healthcare/biotech.
- May consider equivalent combinations of education and experience.
Required Skills/Knowledge:
- Strong working knowledge of FDA, EMA, and international CMC regulations and guidance across multiple modalities.
Application Instructions:
- Apply now.
- Lead and manage a team responsible for authoring and coordinating CMC regulatory submissions across biologics, small molecule, cell/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.
- Establish and track operational metrics (cycle time, submission quality, on-time delivery) to identify bottlenecks and drive measurable efficiency improvements.
- Manage team capacity and workload distribution across concurrent submissions; identify resourcing gaps and reallocate support during peak periods.
- Mentor, coach, and develop staff; represent the company in industry professional associations to shape the external regulatory environment.
Qualifications/Requirements:
- BS/BA in a life sciences discipline (required).
- Associate Director: 10+ years in healthcare/biotech.
- Director: 12+ years in healthcare/biotech.
- Senior Director: 15+ years in healthcare/biotech.
- May consider equivalent combinations of education and experience.
Required Skills/Knowledge:
- Strong working knowledge of FDA, EMA, and international CMC regulations and guidance across multiple modalities.
Application Instructions:
- Apply now.