Vice President, Regulatory Affairs

Onsite 5 days - Cambridge MA



About KalVista Pharmaceuticals, Inc.


KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a Client, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.

About Sebetralstat


Sebetralstat is an investigational, Client oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.


For more information about KalVista, please visit or follow on social media at @KalVista and LinkedIn .

About The Role


KalVista seeks a dynamic and experienced Vice President, Regulatory Affairs to expand, enhance and manage all aspects of our global Regulatory Affairs function. Reporting to the Sr. VP, Regulatory Affairs & Quality Assurance, you will be an integral member of the Senior Leadership Team accountable for providing leadership and expert regulatory input to the strategic direction and long-term success of KalVista. Key responsibilities include ensuring the submission of regulatory applications are in line with Corporate goals while establishing regulatory guidelines that meet compliance requirements at all times.

Responsibilities

• Ensure regulatory objectives are met to support the Corporate Goals
• Guide and direct the regulatory team to ensure appropriate regulatory strategy and regulatory requirements are met for all early development/late development/commercial products
• Guide, mentor and direct the regulatory team to ensure a highly functioning team, resourced to enable Corporate Goals to be met
• Management of the annual budget for Regulatory Affairs
• Provide input/expert review of regulatory submissions as required (e.g. CTA/IND, Orphan Drug Designations/Fast Track/Breakthrough Designations NDA/MAAs)
• Ensure maintenance of good rapport/communication with all Competent Authorities
• Review and approve regulatory SOPs as needed and ensure regulatory affairs function is compliant with all aspects of the QMS
• Support RoW functions in regulatory due diligence activities
• Maintain an up-to-date knowledge of all applicable FDA/EU/other international regulations and laws and undertake training and/or information sharing with colleagues to ensure KalVista implements appropriate processes to maintain compliance

Qualifications

• Bachelor's degree required. Advanced degree preferred
• 20+ years experience in global regulatory affairs, including hands on preparing/writing/submitting of at least one NDA or M nd management of post-approval regulatory activities
• Experience providing regulatory support for early phase development (bench to Phase II) is preferred
• A proven, driven leader able to guide, direct and challenge the status quo across International & functional boundaries
• Excellent communicator and problem solver with the ability to influence at the Executive and Board level and experience working with FDA Divisional Heads & Regulatory Project Managers as well as OUS regulatory agencies
• Ability to thrive under pressure to deliver on complex projects on exacting timelines