Director, Regulatory Affairs

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. Impact: Contribute directly to a medicine with best‑in‑class Phase3 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 Act as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex regulatory CMC topics. Lead negotiations with regulators for initial INDs/CTAs, amendments, and future marketing registration applications. Establish and execute high‑quality CMC related submissions including INDs/CTAs or amendments in collaboration with research, process & analytical development, manufacturing, and other SMEs. Stay 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 proposed manufacturing process changes, provide expertise on raw materials management, DP/DS specifications and release, process characterization & validation, methods development & validation, and provide strategic regulatory guidance to enable implementation. Participate in regulatory intelligence activities related to global CMC regulations and guidance and integrate them into program plans. Maintain responsibility for all CMC Regulatory timelines, and manage contract staff and vendors relevant to CMC activities. Build and maintain strong relationships with internal and external stakeholders. Skills and Requirements PharmD or PhD preferred with ≥8 years of industry experience in Regulatory CMC biologics. Strong scientific background and training in manufacturing processes and development of combination biologic/device products required. Small molecule and medical device experience are a plus. Experience working with FDA sCDER is required. Strong background & track record in filing regulatory submissions from early development to pre‑ and post‑approval submissions and product lifecycle management in the area of biologic medicinal products. Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution in US/ex‑US. Experience interfacing with FDA and other global health authorities. Demonstrated risk identification and critical thinking skills. Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities in biologics. Ability to interact effectively across all levels of the organization; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives. Recognized as an influential leader who possesses a cross‑functional collaborative skill set. Strong oral and written communication skills with strong attention to detail and the ability to coordinate multiple activities in a fast‑paced biotech environment. Able and willing to author regulatory documents as needed and provide guidance to subject matter experts on authoring regulatory appropriate CMC reports and assessments. Salary The salary range for the Director, Regulatory CMC is expected to be between $200,000 and $220,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job‑related skills, experience, education or training, market factors, and work location. The salary range for the Senior Director, Regulatory CMC is expected to be between $250,000 and $265,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job‑related skills, experience, education or training, market factors, and work location. Benefits At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well‑being so you can thrive at work and beyond. Equal Opportunity Statement As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. 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