Associate Director, Regulatory Affairs

Role Summary

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
• 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 Kal Vista’s Regulatory Intelligence process
• Maintain compliance with Kal Vista’s Quality Management System and work to industry standards of GxP

• Minimum of Degree in Chemistry, Pharmacy or a Biological Science
• Minimum of 10 years’ experience in Regulatory Affairs
• Experience of FDA, Health Canada and LATAM regulatory submissions
• Experience of 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