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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.
About EKTERLY (sebetralstat)
EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections.
About The Role
KalVista seeks a highly motivated and knowledgeable Associate Director, Regulatory Affairs to support the development and execution of our international regulatory strategy. Reporting to the Executive Director, Head of International Regulatory Affairs & Regulatory Operations, you will play a key role in ensuring regulatory compliance and contributing to the successful commercialization of KalVista’s products.
Responsibilities
* Review promotional and non-promotional materials for regulatory compliance
* Regulatory lead for international CMLR (Commercial/Medical/Legal/Regulatory) activities
* Support international MAA submission, approval and post approval activities, 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
* Work closely with other regulatory team members to draft/put in place appropriate processes (SOPs) to ensure ongoing maintenance/regulatory compliance of marketing authorizations in international markets
* Impact and influence key leaders and cross-functional groups including Business Development, Commercial, Medical Affairs, Pharmacovigilance, Supply Chain and Quality, while also becoming a significant RA team leader
* Contribute to KalVista’s Regulatory Intelligence process
* Work in conjunction with launch teams, interact with competent authorities and regulatory agencies, and manage consultant and vendor relationships
* Maintain compliance with KalVista’s Quality Management System and work to industry standards of GxP
Qualifications
* Minimum of BSc in Chemistry, Pharmacy or a Biological Science
* Minimum of 10 years’ experience in Regulatory Affairs
* Experience in the review of promotional and non-promotional materials for regulatory compliance
* Experience of Centralized Marketing Authorization Applications
* Experience of post approval license maintenance activities
* Experience of preparing and submitting Marketing Authorizations in other international markets desirable
* Experience in developing and writing SOPs/Work Instructions for post commercial regulatory compliance processes
* Outstanding communication (written and verbal) skills and willingness to share information
* Ability to plan and execute projects to tight deadlines
* An excellent team player with a proven ability to manage projects as part of an interdisciplinary team
We are an equal opportunities employer and welcome applications from all qualified candidates.
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