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
- Effectively negotiate alignment with Otsuka parent and affiliate organizations on strategy & messaging to produce optimal outcomes from global health authority interactions.
- Oversee interactions with FDA and global health authorities (Pre-IND, IND/CTA submissions, End-of-Phase 1 meetings), ensuring high-quality and strategic content.
- Establish and maintain relationships with KOLs to anticipate regulatory expectations and influence regulatory decision-making.
Cross-functional Collaboration & Internal Leadership
- Own and navigate high-level matrixed relationships with affiliate partners.
- Act as a strategic partner to Clinical Operations, Translational Medicine, Nonclinical, CMC, Quality, and Business Development teams, ensuring regulatory considerations are integrated early in decision-making.
- Work with Clinical Operations and Translational Medicine to ensure clinical study designs incorporate both short- and long-term regulatory strategies.
- Work with Quality Assurance to maintain regulatory compliance for US and ex-US clinical studies, ensuring adherence to regional requirements and global regulatory harmonization, and providing support for audits and regulatory inspections
CMC Regulatory Strategy & Execution
- Define and oversee phase-appropriate CMC regulatory strategy for biologics, including CMC regulatory-specific risk mitigation, and ensuring seamless progression from discovery through early clinical development.
- Lead and align the regulatory strategy for Visterra programs' CMC HA submissions (e.g., compilation of M3 (CMC) sections for INDs/CTAs, CMC amendments, IMPD Amendment, annual reports, agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development.
- Provide regulatory oversight for CMC development plans, including comparability strategies, stability programs, analytical method validation, and manufacturing controls.
- Monitor evolving CMC regulatory expectations for biologics and advanced therapeutics, and partner with Quality teams to ensure alignment with CMC-regulatory requirements.
- Support CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) pertaining to the preparation and content of CTA/IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.
- Support best practice for regulatory CMC compliance activities including, but not limited to, change controls.
Regulatory Intelligence & Policy Development
- Stay abreast of changing regulatory requirements and emerging guidance related to biologics, antibody-drug conjugates, and combination products.
- Provide periodic regulatory intelligence insights to senior leadership, proactively identifying regulatory trends impacting nonclinical, PST/CMC, and clinical development strategies.
- Contribute to global regulatory policy discussions, ensuring Visterra's early-stage programs align with future industry standards.
People & Organizational Development
- Enhance regulatory processes and cross-functional collaboration to improve efficiency and compliance. Lead initiatives to strengthen team capabilities and optimize workflows/processes with evolving business and compliance needs.
- Provide mentorship, guidance, and career development opportunities to direct reports while enabling their autonomy in program-level execution.
QUALIFICATIONS & EXPERIENCE:
- Advanced degree in a relevant field (PhD, PharmD, MS, or equivalent).
- Immunology and/or nephrology regulatory experience preferred.
- 15+ years of global regulatory affairs experience, including at least 5 - 7 years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
- Strong knowledge of FDA, EMA, PMDA, and ICH regulatory requirements for biologics and advanced therapeutics.
- Proven experience developing strategies and compiling M3 (CMC) sections for INDs and CTAs.
- Demonstrated leadership in clinical study designs to ensure alignment with regulatory expectations across development stages.
- Experience managing and mentoring regulatory professionals.
- Ability to work cross-functionally and lead in a matrixed, global organization.
- Exceptional collaboration, negotiation and stakeholder management skills to align global regulatory priorities across parent and affiliate organizations.
KEY SUCCESS FACTORS:
- Ability to develop and communicate a clear regulatory vision for early development of biologic programs.
- Strong strategic and critical thinking skills to anticipate regulatory challenges and proactively develop solutions.
- High emotional intelligence and leadership skills to mentor direct reports while allowing them ownership of their projects.
- Ability to build strong relationships with regulatory agencies, internal stakeholders, and global affiliates, ensuring regulatory alignment and optimal decision-making.
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.