About the role

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.

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 and interpret evolving global regulatory trends, guidance, and policy changes relevant to assigned programs or therapeutic areas.

Assess the impact of regulatory intelligence on development and lifecycle strategy.

Required Qualifications

Bachelor’s degree required; Relevant advanced degree preferred (PhD, PharmD, MD, MSc, or equivalent in life sciences).
Skills & Tags
go ai ios data product

Aplyr's read

Vor Biopharma pioneers in engineered cell therapies, attracting professionals driven to transform cancer treatment and tackle serious diseases.
Synthesized from recent postings & public sources

What's promising

•Vor Bio focuses on innovative cell therapies, a promising area in cancer treatment.
•Recent expansions in regulatory and advocacy roles indicate strategic growth.
•Strong leadership in neuromuscular and rheumatology diseases suggests diverse therapeutic focus.

What to watch

•Biotechnology sector faces high regulatory scrutiny, impacting timelines.
•Dependence on successful clinical trials poses financial risks.
•Limited public information about commercialized products or revenue streams.

Why Vor Biopharma

•Vor Bio specializes in engineered cell therapies, setting it apart in oncology.
•Emphasis on patient advocacy roles highlights a patient-centered approach.
•Strategic hires in IT and biostatistics suggest robust data infrastructure.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Vor Biopharma

Vor Biopharma

vorbio.com

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Vor Bio is a biotechnology company focused on developing transformative therapies for patients with cancer and other serious diseases using engineered cell therapies.