Director/ Senior Director, Regulatory CMC

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. 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. , research process & analytical development, manufacturing, and other SME’s).

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 as they pertain to global CMC regulations and guidance and integrate into program plans. · Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities. · Build and maintain strong relationships with internal and external stakeholders.

: · PharmD or PhD preferred with ≥8 years of industry experience in Regulatory CMC biologics. Strong scientific background and training in manufacturing processes and development and development of combination biologic/device products are required. Small molecule and medical device experience are a plus.

Experience working with FDA sCDER is required.