New

Associate/Director, Regulatory Submissions

Boston

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.

 

Associate Director / Director, Regulatory Affairs – Regulatory Submissions

Position Summary

Vor Bio is seeking an experienced and detail-oriented Associate Director or Director of Regulatory Affairs to lead and manage global regulatory submissions across clinical development programs, with a focus on autoimmune indications. This role will be responsible for planning, preparing, and executing regulatory submissions for global clinical trials and product registrations, ensuring compliance with international regulatory requirements and timelines. The ideal candidate will bring strong technical expertise in biologics development, autoimmune clinical trial experience, and a collaborative mindset to support cross-functional teams and external partners.

Key Responsibilities

  • Lead the preparation, review, and submission of regulatory documents including INDs, CTAs, briefing packages, and other regulatory filings across US, EU, LATAM, and APAC regions.
  • Serve as the regulatory submission lead for assigned autoimmune programs, ensuring high-quality, timely, and compliant submissions.
  • Collaborate with cross-functional teams (clinical, medical writing, CMC, safety, biostats) to ensure submission readiness and alignment with development timelines.
  • Support regulatory strategy execution by contributing to regulatory planning, risk assessments, and mitigation strategies.
  • Manage regulatory interactions with CROs and vendors, including oversight of submission packages and responses to health authority queries.
  • Monitor evolving global regulatory requirements and provide guidance to internal teams on implications for submissions and trial conduct.
  • Participate in health authority meetings and support the development of briefing documents and meeting requests.
  • Maintain submission tracking systems and ensure documentation is archived in accordance with internal SOPs and regulatory standards.
  • Contribute to inspection readiness activities and support audits related to regulatory submissions.

Qualifications

  • Bachelor’s or Master’s degree in life sciences, pharmacy, or related field.
  • 8+ years of regulatory affairs experience in the biotech/pharmaceutical industry, with a focus on regulatory submissions.
  • Proven experience preparing and submitting INDs, CTAs, and other regulatory documents in global markets.
  • Strong understanding of ICH/GCP, FDA, EMA, and other international regulatory requirements.
  • Hands-on experience with biologics and autoimmune clinical development programs.
  • Excellent project management, organizational, and communication skills.
  • Ability to work independently and collaboratively in a fast-paced, matrixed environment.
  • Proficiency in regulatory systems and Microsoft Office tools.
  • Willingness to travel up to 10% as needed.

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.

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.

Please visit our website at https://www.vorbio.com/ for more information.

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