Director, 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, 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.

When & where:

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

Discover your role:

• 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
• 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

This role requires:

• 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 equivalent combination of education and experience. Level is determined based on qualifications relevant to the role

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$147,800.00 - $338,400.00