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.When & where:Location: Troy, New York, United StatesWork model: Monday - Friday 8am - 4:30pmDiscover 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 lifecycleDevelop and implement global CMC regulatory strategies for product development and lifecycle management, aligning with business objectives and accelerating time to approvalBuild 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 timelinesEstablish and track operational metrics such as cycle time, submission quality, and on-time delivery to identify bottlenecks and drive measurable improvements in team efficiencyManage team capacity and workload distribution across concurrent submissions, proactively identifying resourcing gaps and reallocating support during peak submission periodsMentor, coach, and develop staff to build bench strength and technical capability; represent the company in industry professional associations to help shape the external regulatory environmentDemonstrated experience managing or leading a team with a track record of developing talent and scaling team outputStrong working knowledge of FDA, EMA, and international CMC regulations and guidance across multiple modalitiesThis role requires:BS/BA in a life sciences discipline requiredAssociate Director: 10+ years of experience in the healthcare or biotech industryDirector: 12+ years of experience in the healthcare or biotech industrySenior Director: 15+ years of experience in the healthcare or biotech industryMay consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the roleDoes 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 s...