Kristin Murray

In my role as Senior Vice President Regulatory Affairs and Quality Assurance at SIGA Technologies, I oversee a dedicated team focused on developing medicines for emerging infectious diseases. By implementing robust regulatory strategies combined with quality compliance, we ensure compliance with industry standards and guidelines, leading to successful global approvals and commercialization.

Regulatory consultant providing technical CMC expertise, strategy and support across product modalities and phases of development. Demonstrated strategic thinking, written and verbal communication skills, and ability to work effectively in a collaborative environment. Clients include: Leading pharmaceutical company, providing expertise supporting gene therapy BLA o Includes interfacing with CMO on registering new multiproduct manufacturing facility Small biotech company, providing regulatory CMC strategy supporting development of a complex viral vaccine product in Phase 2 clinical trials o Includes development of comparability approach across product components and conversion of paper IND to eCTD format to support Phase 2 INDa Pharmaceutical company developing topical small molecule product, providing expertise supporting initial NDA

Oversee a world-class regulatory consulting team offering comprehensive expertise across all stages of development, different product modalities (small molecules, oligonucleotides, biologics, advanced therapies, devices, and combination products) catering to organizations of all sizes. Maintained focus on clinical and nonclinical strategies, regulatory CMC and regulatory operations, and oversaw associated budget and resourcing models. • Developed commonsense and phase-appropriate regulatory strategies for development teams and global submissions supporting 200+ clients across the product lifecycle • Led development of strategic approaches and accompanying regulatory documents to support global Health Authority meetings and to secure global approvals for IND/CTA through BLA/MAA • Developed country-specific clinical development strategies to support global clinical trial expansion, including regulatory gap assessment and risk mitigation strategies • Identified and managed critical regulatory issues throughout the product lifecycle • Leveraged and prepared applications for special regulatory designations and accelerated approval pathways • In collaboration with Syner-G’s medical writing team, oversaw regulatory writing (author/review) for all modules of the common technical document (eCTD) from IND/CTA to BLA/NDA/MAA

Responsible for all aspects of Regulatory Affairs and Quality across the product lifecycle related to clinical development, CMC, and commercialization strategies of a gene therapy (plasmid DNA) products while overseeing department activities and cross-functional teams. Proactively identify and assess regulatory risks for Xalud’s projects and programs and strategically develops regulatory approaches to address and resolve these risks, working proactively with global health authorities. While keeping current on global regulatory guidelines and trends, served as primary regulatory agency contact (at the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for Xalud. Oversaw global regulatory writing and strategy for all regulatory documents. Responsible for designing and implementing a quality system from scratch to meet GxP requirements for Xalud’s products. Develops robust regulatory and quality structures, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy. Oversees long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.

Led and managed the Regulatory CMC team of 10 for the gene therapy division. • Led development of global regulatory CMC strategies for 3 gene therapy programs, including development of global submissions and oversight of Health Authority interactions • Key partner and interface between Regulatory CMC and Technical Operations/Quality responsible and accountable for strategic CMC regulatory guidance and expertise • Ensured that all applicable regulatory requirements/options and associated risks were considered and appropriately incorporated into development programs • Provided guidance and advice on regulatory CMC environments including assessment of the new and changing regulations/requirements

Built, integrated, led and mentored a global regulatory CMC team of 88 strategists and 40 consultants with over 80 development and commercial programs across Neuroscience, Oncology, Immunology, and other rare disease therapeutic areas. Known for strategic thinking, developing creative solutions to challenging regulatory issues and ability to work effectively across diverse teams. -Orchestrated and executed contemporary regulatory CMC strategies for global development programs to facilitate the likelihood of successful product registration -Strategically developed global CMC baseline dossier program to ensure sustainable lifecycle of globally marketed products and enables rapid global expansion -Led and participated in strategic meetings with global Health Authorities. -Partnered with Quality & Technical Operations overseeing regulatory compliance at external CMOs and across internal sites. -Oversaw and actively participated in due diligence initiatives; in-licensing and separation, including serving as the Regulatory point of contact for the Baxalta integration process -Sponsored and participated in multiple initiatives across Shire including BLA/MAA content template team, compliance reports, regulatory intelligence, stage gate process geared at continuous improvement and streamlining processes. -Actively involved in industry advocacy teams and working groups developing contemporary and progressive approaches to regulatory CMC

·Orchestrates the regulatory strategy in conjunction with business and project goals for medicinal drug submissions to global regulatory authorities ·Manages face-to-face meetings and teleconferences with global regulatory authorities ·Leads tasks forces with cross-functional and cross-site teams ·Leads key discussions, project updates and/or proposals for consideration, and actively engages key stakeholders in decision-making processes for critical issues ·Provides the regulatory leadership for implementation of Quality Risk Management principles, processes, and tools across sites ·Coordinates, manages, and executes risk assessments in accordance with ICH, FDA, IEC, and ISO requirements for QRM. ·Provides project management, team and meeting facilitation, and training for QRM programs and initiatives ·Areas of regulatory focus include analytical method validation, product characterization, QRM, QbD, and facility and equipment design, operation, control and validation

·Managed a small group responsible for the discovery, development, characterization, and qualification of immunoassays using contemporary chemistry, biochemistry and other analytical approaches. ·Responsible for the technical transfer of analytical methods to internal support laboratories, and routine monitoring of support laboratory performance ·Routinely presents project updates and/or proposals for consideration, and actively engages key stakeholders in decision-making processes for critical issues ·Co-led an exclusive test agreement (one of four labs worldwide) with Biacore and Bruker for further development of their joint SPR-MS technology ·Actively involved with project planning and project coordination across various functional areas for multiple concurrent projects ·Responsible for coordination and tracking of a development projects' progress through project maturity, including resource tracking, budget issues, project timelines, etc.