Senior Director, Regulatory Affairs

Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team’s activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization.

The Senior Director of Regulatory Affairs will report to the Chief Medical Officer and manage a small Regulatory Affairs team supporting Visterra’s biologic programs. This highly visible leadership role is responsible for developing and executing regulatory strategy, ensuring regulatory compliance across early-stage development, and optimizing global health authority interactions. The Senior Director will collaborate cross-functionally with internal teams and align regulatory strategies with affiliate and parent organizations. Additionally, this role will provide regulatory intelligence and CMC oversight, while driving continuous improvement and best practices.

PRIMARY RESPONSIBILITIES

Regulatory Strategy & Leadership

• Develop and drive the regulatory strategy for early-stage biologics, including monoclonal antibodies, Fc fusion proteins, bispecific / trispecific antibodies, and other innovative formats.
• Develop and articulate a vision for regulatory best practices across the program lifecycle, orphan drug designation strategies, accelerated development opportunities, including indication sequencing, and pediatric study planning (PSP / PIP requirements).
• Provide high-level regulatory support for nonclinical development programs for IND / CTA-enabling studies, ensuring compliance with global regulatory expectations.
• Ensure seamless transition of regulatory responsibilities / ownership to Otsuka partners post-Proof of Concept trials, ensuring high quality INDs and CTAs to minimize risks for BLA submissions.

Oversight of Regulatory Health Authority Engagement in Early Development

Cross-functional Collaboration & Internal Leadership

CMC Regulatory Strategy & Execution

Regulatory Intelligence & Policy Development

People & Organizational Development

QUALIFICATIONS & EXPERIENCE :

KEY SUCCESS FACTORS :

COMPANY

Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 125 employees and is located in Waltham, Massachusetts.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.