Principal Medical Writer

Principal Medical Writer

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-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 indicationa therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjgren's syndrome.

Belonging : Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.

Role Overview

As a key member of the R&D team, the head of regulatory affairs strategy is responsible for developing and implementing innovative regulatory strategies to expedite clinical development, product registration, and commercialization of our portfolio of investigational products globally.

In a biotech environment, you will act as the regulatory lead on relevant project teams to define and execute development strategies for these programs. This role will be the global regulatory lead and internal expert for the global clinical development in the autoimmune disease area, providing regulatory guidance to cross-functional project teams, ensuring compliance with international regulations, assessing regulatory risks, and engaging with health authorities. You will be the primary contact for interfacing with the FDA and will lead cross-functional teams to deliver both domestic and international regulatory submissions, including IND, CTA, BLA NDA, and MAA submissions.

Key Responsibilities

• Provide overall executive leadership in creating and executing global regulatory strategies for product development.
• Serve as a key member of the R&D leadership team to ensure the development plan is aligned with regulatory requirements and business objectives.
• Identify and assess regulatory risks associated with development programs and define approaches to mitigate risks.
• Represent the company in important direct communications with regulatory agencies such as meetings with agencies.
• Manage and coordinate all aspects of Health authorities' interactions, including FDA meetings and advisory committee preparation in the US, scientific advice in Europe, or key meetings with PMDA in Japan.
• Lead preparation and submission of major regulatory application (INDs, CTAs, MAAs, NDAs / BLA, amendments and supplements). Review and endorse key development documents (such as e.g, HA briefing books, eCTD module 2, labeling, pivotal protocols / reports, orphan designations, pediatric plans, risk management plans etc).
• Take ownership in ensuring that all regulatory deliverables are of highest quality and that all regulatory submission requirements are met in a timely manner.
• Collaborate closely with cross-functional teams including clinical, biostatistics, drug safety, clinical pharmacology, non-clinical, CMC, project management, QA and commercial teams.
• Represent Regulatory Affairs in assigned project and clinical team meetings and serve as an internal expert by providing strategic and operational regulatory guidance to management and project teams for the international clinical development and registration of new products or new indications, especially for the US, EU, Japan.
• Provide regulatory leadership and sponsor level oversight for Clinical Trial Applications (CTAs) in studies in different global regions. Partner with the CRO to develop and implement innovative and compliant solutions. Review CTA submission packages, RFIs, sponsor responses to ensure quality and timeliness of submissions.
• Keep abreast of and monitor latest regulatory trends. Maintain up-to-date knowledge of global regulatory requirements.
• Recruit, develop, and mentor (junior) personnel in Regulatory Affairs while also managing external, contracted resources (CRO) and / or business partners.

Qualifications

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.