Employer profile
Kalvista Pharmaceuticals INC
3 open roles indexed with location, benefit, and apply-link signals where available.
Open roles
Showing the most recent indexed roles for this employer.
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Associate Director, Regulatory Affairs
Salisbury, UK
unspecified Salary not disclosedAssociate Director, Regulatory Affairs Salisbury, UK About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®-the first and only oral on-demand treatment for hereditary angioedema (HAE)-and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn , X , Facebook and Instagram . ABOUT THE ROLE The Associate Director, Regulatory Affairs will join the Regulatory Development team at KalVista in contributing to the development of regulatory submissions in alignment with company objectives and support the successful commercialization of KalVista's products. The position provides regulatory expertise and guidance across both pre and post approval activities, serving as the regulatory lead for designated territories. Responsibilities include ensuring ongoing regulatory compliance within those territories while partnering cross-functionally to support strategic and operational regulatory requirements. RESPONSIBILITIES Support IND/NDA/MAA preparation, submissions, assessment and post approval activities in designated territories, in close collaboration with the Global Regulatory Lead Represent regulatory affairs in allocated launch teams as required Provide regulatory support to business development, commercial, market access, pharmacovigilance, supply chain and quality functions Working closely with other regulatory team members, to draft/put in place appropriate processes (SOPs) to ensure ongoing maintenance/regulatory compliance of marketing authorizations in designated markets Contribute to KalVista's Regulatory Intelligence process Maintain compliance with KalVista's Quality Management System
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Regulatory Affairs Manager
Sailsbury, UK
unspecified Salary not disclosedRegulatory Affairs Manager Sailsbury, UK About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®-the first and only oral on-demand treatment for hereditary angioedema (HAE)-and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn , X , Facebook and Instagram . ABOUT THE ROLE The Regulatory Manager is responsible for managing regulatory submissions and maintaining regulatory documentation to ensure compliance with global marketing authorizations and global clinical trial applications. This role supports cross-functional teams, contributes to regulatory strategy execution, and ensures regulatory requirements are consistently met across all assigned projects. RESPONSIBILITIES Maintain eCTD and IMPD documentation, ensuring consistency, accuracy, and continuous regulatory compliance Provide regulatory support for projects to ensure submission of Competent Authority application in line with project goals Support planning, preparation, and maintenance of regulatory documentation in collaboration with subject matter experts Contribute to development and submission of DSURs, PIPs/PSPs, Orphan Drug Designation applications, Fast Track applications, and other regulatory documents Provide regulatory support for expanded access/compassionate use programs (EAPs) Support preparation for Regulatory Agency interactions, including scientific advice meetings Review, quality-check, and approve regulatory updates per internal procedures Maintain regulatory systems, databases, and trackers Participate in project team meetings, providing regulatory guidance Identify regulatory gaps and collaborate to implement solutions
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Associate Director, Commercial Supply Planning
Framingham, US
unspecified $175K-$205KAssociate Director, Commercial Supply Planning Framingham, US About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®-the first and only oral on-demand treatment for hereditary angioedema (HAE)-and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn , X , Facebook and Instagram . ABOUT THE ROLE KalVista seeks a highly motivated and knowledgeable professional to join us as Associate Director, Commercial Supply Planning. Reporting to the Senior Director, Supply Planning and Network Strategy, this role will lead supply planning activities for both US and Global Commercial programs. As a key member of the planning team, you will develop an all-encompassing strategy focusing on New Product Introduction (NPI) to lifecycle management of all marketed products at KalVista. This role will also place a high emphasis on planning in an ERP environment (SAP), along with reporting the “health” of our supply chain through generation of robust metrics and KPIs. Our ideal candidate will possess a strong skillset required to translate fluid forecasts into working production plans, pre and post launch activities and aligning cross functionally in execution of product to patient. RESPONSIBILITIES Maintain target level of end-to-end supply across all regions. Ensure demand and supply are accurately reflected and executed in SAP Oversee the Supply