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.
The Associate Director, Regulatory Affairs will join the Regulatory Development team at KalVista and contribute 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
* Work closely with other regulatory team members to draft and implement 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 and work to industry standards of GxP
IMPACT/INFLUENCES
* Regulatory Affairs Department
* Business development, Commercial, Medical Affairs, Pharmacovigilance, Supply Chain and Quality functions
* Launch teams
* Competent Authorities and Regulatory Agencies
* Consultants and Vendors
QUALIFICATIONS
* Minimum of a Degree in Chemistry, Pharmacy or a Biological Science
* Minimum of 10 years’ experience in Regulatory Affairs
* Experience with FDA, Health Canada and LATAM regulatory submissions
* Experience with post‑approval maintenance activities
* Experience in developing and writing SOPs/Work Instructions for post‑commercial regulatory compliance processes
* Outstanding written and verbal communication skills and willingness to share information
* Ability to plan and execute projects to tight deadlines
* Excellent team player with a proven ability to manage projects as part of an interdisciplinary team
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