Senior CMC Regulatory Intelligence Specialist

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 CMC Regulatory Intelligence Specialist (Specialist or Senior Specialist) to join our IOPS Regulatory Sciences team, monitoring and communicating changes in the global CMC regulatory landscape to ensure our manufacturing organization remains in compliance with evolving global requirements. In this role, you will assess regulatory intelligence, facilitate cross-functional working groups, and translate emerging trends and risks into actionable guidance — while collaborating with Regulatory Affairs, Quality, and manufacturing stakeholders across the organization. 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 mode: Monday - Friday 8am - 4:30pm Discover your role: Monitor and assess global CMC regulatory intelligence for relevance and impact to internal processes, drug development projects, and regulatory strategies; communicate findings effectively to internal stakeholders Establish working groups, facilitate discussions, and lead presentations that examine emerging regulatory trends and risks, bringing together subject matter experts from across departments and levels to ensure compliance Collaborate with Regeneron's Global Regulatory Intelligence Department to support public commenting on regulatory drafts and monitor the evaluation and implementation of final CMC regulations and guidelines Engage with the quality management system to record and track actions required to maintain compliance with new and updated regulatory guidance Author CMC regulatory intelligence reports and newsletters distributed to the manufacturing organization; provide regulatory intelligence support for queries related to global CMC requirements Represent Regeneron on industry collaboration forums examining existing and emerging CMC topics, contributing to connected solutions that drive change Participate in shaping the tools and processes that support regulatory intelligence operations at Regeneron Strong understanding of global CMC regulations and guidance across major health authorities including FDA and EMA preferred Excellent written and verbal communication skills with demonstrated ability to synthesize complex regulatory information into clear, actionable narratives for varied audiences Experience engaging with industry working groups or professional associations a plus This role requires: BS/BA in Life Sciences Specialist: 2+ years of relevant pharmaceutical industry experience Senior Specialist: 5+ years of relevant pharmaceutical industry experience May consider equivalent combination of education and experience; level determined based on qualifications 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