Senior Director/ Director Regulatory Strategy

J oin 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. Location: Boston, MA preferred The Senior Director/ Director Regulatory Strategy provides global regulatory leadership and strategic direction across one or more development programs in immunology. This role is accountable for shaping and executing regulatory strategies that enable timely product development, approval, and lifecycle management while ensuring compliance with global regulatory requirements. The Director acts as a strategic partner to R&D, Clinical, Quality, CMC, Commercial, and represents the organization in high ‑ level interactions with global regulatory authorities. Key Responsibilities Regulatory Strategy & Leadership Develop and lead global, integrated regulatory strategies for investigational and marketed products across the product lifecycle, including late stage development. Provide strategic input on development plans, target product profiles, labeling, indications, and sequencing of regulatory submissions. Anticipate and mitigate regulatory risks; proactively identify opportunities for regulatory flexibility, expedited programs, and innovative pathways. Serve as a key regulatory advisor to senior leadership and cross ‑ functional governance bodies. Regulatory Agency Engagement Lead and/or oversee global regulatory authority interactions, including IND/CTA meetings, End ‑ of ‑ Phase meetings, scientific advice, and other milestone interactions. Develop briefing documents, talking points, and negotiation strategies aligned with program objectives. Interpret and communicate regulatory feedback to cross ‑ functional teams and translate it into actionable plans. Submissions & Execution Oversight Provide strategic oversight for major regulatory filings (e.g., INDs/CTAs, NDAs/BLAs/MAAs, supplements, variations). Ensure submission strategies are aligned with global regulatory expectations and business priorities. Review and approve regulatory strategy documents, submission plans, and key content from a strategic perspective. Cross ‑ Functional Collaboration Partner closely with Clinical Development, Biostatistics, CMC, Nonclinical, Pharmacovigilance, Quality, and Commercial teams to align regulatory strategy with development and commercialization goals. Influence program decision ‑ making by integrating regulatory considerations early and consistently. Support due diligence, licensing, and business development activities from a regulatory standpoint. People & Matrix Leadership Mentor and develop regulatory strategists and/or regulatory leads; provide strategic oversight within a matrixed team environment. Contribute to the evolution of regulatory strategy capabilities, processes, and best practices within the organization. Promote a culture of scientific rigor, regulatory excellence, and proactive risk management. Policy & Intelligence Monitor a…