Vice President, Regulatory Affairs

Kalvista Pharmaceuticals - Cambridge, MA

Full-time - Executive

Cambridge, MA

Chemical Manufacturing

About the position

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

Requirements

• 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 MAA and 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