Associate Director, Regulatory Affairs

Kal Vista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The Kal Vista 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.

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. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide.

The Associate Director, Regulatory Affairs will join the Regulatory Development team at Kal Vista in contributing to the development of regulatory submissions in alignment with company objectives and support the successful commercialization of Kal Vista’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.

• 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/implement appropriate processes (SOPs) to ensure ongoing maintenance and regulatory compliance of marketing authorizations in designated markets
• Contribute to Kal Vista’s Regulatory Intelligence process
• Maintain compliance with Kal Vista’s Quality Management System and work to industry standards of GxP

• Regulatory Affairs Department
• Business development, Commercial, Medical Affairs, Pharmacovigilance, Supply Chain and Quality functions
• Launch teams
• Competent Authorities and Regulatory Agencies
• Consultants and Vendors

• Minimum of 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 in post approval maintenance activities
• 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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay Range: $185,000 - $205,000 USD