Director/ Senior Director, Regulatory CMC

Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.    Vor Bio is seeking an exceptional and highly motivated CMC leader Director/Sr Director Regulatory CMC to join our team. The qualified candidate will work cross-functionally to lead development and implementation of robust regulatory CMC strategies & tactics across programs and lifecycle stages to support our company objectives. As a result, the candidate will play a vital role in helping to progress our lead program, telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, through clinical development and global registration. The candidate must be a highly effective leader as they will be relied upon to drive robust CMC strategic plans throughout development. This individual should also have strong interpersonal skills and a demonstrated track record with regulatory agencies. Extensive experience in the development of biologics and combination biologic/device products is a must. Key areas of responsibility: · As a member of the CMC project teams, act as Regulatory CMC Lead for assigned programs providing strategic guidance to development team(s) on complex regulatory CMC topics. · Responsible for leading negotiations with regulators as applicable for initial INDs/CTAs, amendments and future marketing registration applications. · Accountable to establish and execute high-quality CMC related submissions including INDs/CTAs or amendments working in collaboration with other stakeholders (ie., research process & analytical development, manufacturing, and other SME’s). · Keep abreast of and communicate CMC regulatory requirements to ensure all development activities follow applicable regulations and guidelines. · Provide regulatory strategic and tactical support for CMC aspects such as change control & inspection management. Assess propose...