Director / Sr. Director, Regulatory Affairs

DIRECTOR/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 FIH studies through clinical proof of concept trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization. 

The Director/Senior Director of Regulatory Affairs will report to the Chief Medical Officer and will manage a small team of direct reports with Regulatory Affairs experience in Visterra's biologic programs. The Director/Senior Director of Regulatory Affairs is a highly visible role responsible for ensuring that all clinical, CMC and nonclinical regulatory requirements and goals are met, from pathway planning to submissions, in accordance with industry standards, and integrating rational risk/mitigation strategies. The Director/Senior Director will work closely with the Visterra department heads of CMC, clinical development, translational medicine, and nonclinical development, as well as members of the Regulatory and other line function teams across Visterra and Otsuka.  This role is based in Waltham, MA and is an onsite position.

PRIMARY RESPONSIBILITIES 

The Director/Senior Director, Regulatory Affairs is responsible for:  

• Developing and executing the global regulatory strategy for Visterra’s preclinical and early clinical development assets. 

• Interfacing and aligning with the late phase regulatory unit at Otsuka to ensure global regulatory compliance, continuity through transition to late phase activities, and to set up Otsuka late phase regulatory unit for smooth, successful BLA submission, including strategy for:  

• Surrogate and approval endpoints, and clinical outcome assessments. 

• Special status designations such as orphan drug, fast track and breakthrough designation. 

• Overseeing the timely preparation, review, publishing, and submission of documents to Global Health Authorities (FDA, EMA, PMDA etc.), including but not limited to: 

• IND/CTA/CTN packages including Scientific Rationale, IB, ISI etc. 

• Cross-functional documents including protocols & amendments, DSURs, ICF and exploratory/MoA analyses. 

• Developing pre-IND strategy with respect to timing, type of communications. Accountable for coordinating Health Authority interactions, including leading team through creation of briefing materials and meeting preparation and serving as the key contact for Regulatory interactions. 

• Ensuring compliance with applicable regulatory requirements and best industry practices and informing the company of any changes to requirements and procedures 

• Proactively identifying potential regulatory risks to the strategic/operational plans of Visterra assets, proposing options to mitigate risk, and communicating with internal and external team members, senior leaders, and key stakeholders on the status of, risks and mitigation plans associated with the regulatory milestones. 

• Oversee Registry entries (CT.gov etc.), redactions etc. 

• Regulatory CMC activities: 

• Phase appropriate CMC-regulatory strategy 

• Provide regulatory oversight for change control documentation and related cGMP documentation 

• Identify regulatory risks to the CMC strategic/operational plans  

• Ensure CMC process/workflows are in place related to Health Agency interactions (i.e., briefing documents and responses to questions) 

• CMC regulatory submissions (e.g., original INDs, CMC amendments, IMPD Amendment, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development. 

• Support: 

• CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) on 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. 

Additional activities: 

• Stay updated on and knowledgeable of the Regulations, Guidance, Laws, and ICH Guidelines. 

• Collaborate with Visterra QA to update, author and approve SOPs pertaining to Regulatory activities and documents. 

• Develop and maintain relationships with regulatory authorities, internal departments (e.g., Medical, QA, Clinical Operations, CMC), consultants, and other partners.  

• Drive collaboration with Otsuka affiliate counterparts to ensure delivery of global development-ready regulatory package and smooth transition to late phase development.  

• Make sound judgements taking into consideration patient safety, business risk, and compliance. 

• Support Visterra’s research pipeline and New Target Team in vetting regulatory landscape & precedents for new indications of unmet need & candidate targets.  

• Manage and mentor any direct reports, as necessary. 

PROFESSIONAL EXPERIENCE/QUALIFICATIONS 

• B.S. or MSc, degree within a scientific discipline required with 10-12 years’ experience in US Regulatory Affairs (Biotechnology Industry) preferred. 

• Broad expertise with specific experience in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Nonclinical), ideally with a biologics emphasis. 

• Well-versed in regulatory strategy, and regulatory writing 

• Immunology and/or nephrology regulatory experience preferred. 

• Highly detail oriented with ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills. 

• Effective collaborator who can bring together multiple stakeholders and is able to build positive relationships, with both internal and external partners. 

• Based in the greater Boston, MA area - this is an onsite position in Waltham, MA

LEADERSHIP CHARACTERISTICS 

• Resourceful, collaborative, detail oriented. 

• Approaches challenges with creativity and pragmatism. Ability to work in a fast-moving and challenging biotech environment. 

• Ability to engage teams to achieve goals without direct authority. 

• Driven to move the R&D programs forward at full speed while maintaining quality. 

COMPANY

Visterra is a clinical stage biotechnology company committed to developing innovative biologic therapies for the treatment of kidney diseases, with an immuno-nephrology focus. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. 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 subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 125 employees, and is located in Waltham, Massachusetts.