Associate Director, Regulatory Affairs

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 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. 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.

For more information visit EKTERLY.com.

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.

As a regulatory leader for designated international territories, you will provide expert guidance on regulatory submissions, this role will Contribute to the development of regulatory submissions in line with Company objectives and support the successful commercialization of KalVista’s products ex-USA (“international). This role will also support both pre and post approval activities. Additionally, you will contribute to KalVista’s Regulatory Intelligence process while ensuring all activities align with corporate objectives and global compliance standards.

Responsibilities:

• 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 of Centralized Marketing Authorization Applications

• Experience of post approval license maintenance activities

• Experience of preparing and submitting Marketing Authorizations in UK, Switzerland and 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

Important Notice to Third-Party Recruiters & Staffing Agencies:

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.

Thank you for your understanding and cooperation