Senior Director Director Regulatory Strategy
Job Location:
Boston, MA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 youre not just working on a medicine. Youre 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 Sjögrens 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 highlevelinteractions 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 includinglate stagedevelopment.
- Provide strategic input on development plans target product profiles labeling indications and sequencing of regulatory submissions.
- Anticipate and mitigate regulatory risks; proactivelyidentifyopportunities for regulatory flexibility expedited programs and innovative pathways.
- Serve as a key regulatory advisor to senior leadership andcrossfunctionalgovernance bodies.
Regulatory Agency Engagement
- Lead and/or overseeglobal regulatory authority interactionsincluding IND/CTA meetingsEndofPhasemeetings scientific advice and other milestone interactions.
- Develop briefing documents talking points and negotiation strategies aligned with programobjectives.
- Interpret and communicate regulatory feedback tocrossfunctionalteams 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.
CrossFunctionalCollaboration
- Partner closely with Clinical Development Biostatistics CMC Nonclinical Pharmacovigilance Quality and Commercial teams to align regulatorystrategywith development and commercialization goals.
- Influence programdecisionmakingby 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
- Bachelors degreerequired;Relevant advanced degree preferred(PhD PharmD MD MSc or equivalent in life sciences).
- 7 yearsof progressively responsible experience in Regulatory Affairs within the pharmaceutical industry.
- Demonstrated experience leadingglobal regulatory strategiesfor development programs and/or major regulatory submissions.
- Proven success indirect interactions with global regulatory authorities.
- Experience working in matrixedcrossfunctionaldevelopment teams.
- Remote role; occasional travel required for regulatory meetings and internal governance forums.
Skills & Competencies
- Strong strategic thinking with the ability to balance regulatory risk scientific evidence and businessobjectives.
- Deep understanding of global regulatory frameworks and product development.
- Excellent leadership influence and communication skills including the ability to engage senior executives.
- Ability to navigate ambiguity and drive alignment across diverse stakeholders.
- Strong written and verbal communication skills.
Preferred Qualifications
- Experience in a specific therapeutic areais a plus( immunology neurology).
- Experience with accelerated pathways (e.g. Fast Track Breakthrough Therapy).
- Experience supporting global commercialization andpostapprovallifecycle activities.
The salary range for the Director Regulatory Strategy is expected to be between $210000 and $235000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills experience education or training market factors and work location.
The salary range for the Senior DirectorRegulatory Strategy is expected to be between $250000 and $285000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills experience education or training market factors and work location.
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 for more information.
Required Experience:
Exec
About Company
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. Our goal is to bring life-changing therapies to patients worldwide who are living with serious, autoantibody-driven conditions.
