Director of Operations, CMC Regulatory Sciences

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 147,800 - 338,400; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Director of Regulatory Sciences to lead global CMC strategy across modalities and the product lifecycle, from IND/CTA through NDA/BLA and post-approval maintenance.

The role requires directing CMC submissions, building high-performing teams, and ensuring regulatory compliance while accelerating approvals. Troy, New York-based, standard weekday schedule.

Qualifications

• Requires BS/BA in life sciences and strong track record in regulatory strategy.
• Experience leading CMC regulatory submissions across modalities.
• Proven ability to develop timelines, coordinate teams, and drive approvals.

Responsibilities

• Lead authoring and coordination of CMC regulatory submissions across biologics, small molecules, cell and gene therapies, and combinations.
• Develop and implement global CMC regulatory strategies aligned with product development and lifecycle plans.
• Direct preparation, review, and submission of CMC documentation ensuring scientific rigor and compliance.
• Improve team processes, templates, workflows, and submission tracking to meet timelines.
• Establish and monitor metrics like cycle time, submission quality, and on-time delivery.
• Interact with regulatory authorities to present CMC strategy and interpret regulatory trends for internal policies.
• Manage capacity and workload across submissions, reallocating resources during peaks.
• Mentor staff and represent Regeneron in industry associations to influence external regulatory landscape.

Skills

Regulatory strategy

Leadership

Cross-modality

Regulatory submissions

Education

Bachelor's degree in life sciences

Job description

Job Overview

Director of Regulatory Sciences – leads global CMC strategy across modalities and product lifecycle stages, ensuring scientific rigor and regulatory compliance from first‑in‑human filings through post‑approval maintenance.

Responsibilities

• Lead and manage a team responsible for authoring and coordinating CMC regulatory submissions across all modalities – biologics, small molecules, 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.

Qualifications

• BS/BA in a life sciences discipline required.
• Director: 12+ years of experience in the healthcare or biotech industry; Associate Director: 10+ years; Senior Director: 15+ years. Equivalent combination of education and experience may be considered. 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.
• Demonstrated experience managing or leading a team with a track record of developing talent and scaling team output.

Location / Work Model

Location: Troy, New York, United States. Work model: Monday – Friday, 8am – 4:30pm.

Salary Range

Annually: $147,800.00 – $338,400.00.

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.