Vor Bio

Senior Director/ Director Regulatory Strategy

Boston, MA · Director

Sponsorship not specifiedDetected 51 days ago

Product ManagementBusiness DevelopmentNegotiationPharmacovigilanceLeadershipCollaborationBiostatistics

About the role

When you join Vor, you're not just working on a medicine.
Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.

Develop and lead global, integrated regulatory strategies for investigational and marketed products across the product lifecycle, including late stage development.
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.
Review and approve regulatory strategy documents, submission plans, and key content from a strategic perspective.
Partner closely with Clinical Development, Biostatistics, CMC, Nonclinical, Pharmacovigilance, Quality, and Commercial teams to align regulatory strategy with development and commercialization goals.
Support due diligence, licensing, and business development activities from a regulatory standpoint.
Mentor and develop regulatory strategists and/or regulatory leads; provide strategic oversight within a matrixed team environment.

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.
Interpret and communicate regulatory feedback to cross ‑ functional teams and translate it into actionable plans.
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.
Influence program decision ‑ making by integrating regulatory considerations early and consistently.

Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
At Vor, we believe science can do more than manage symptoms.
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.
You're part of a mission to redefine the future of autoimmune care.

This listing is sourced directly from Vor Bio's careers page and normalized into a canonical job model.