Regulatory Affairs Manager

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 THE ROLE The Regulatory Manager is responsible for managing regulatory submissions and maintaining regulatory documentation to ensure compliance with global marketing authorizations and global clinical trial applications. This role supports cross-functional teams, contributes to regulatory strategy execution, and ensures regulatory requirements are consistently met across all assigned projects. RESPONSIBILITIES Maintain eCTD and IMPD documentation, ensuring consistency, accuracy, and continuous regulatory compliance Provide regulatory support for projects to ensure submission of Competent Authority application in line with project goals Support planning, preparation, and maintenance of regulatory documentation in collaboration with subject matter experts Contribute to development and submission of DSURs, PIPs/PSPs, Orphan Drug Designation applications, Fast Track applications, and other regulatory documents Provide regulatory support for expanded access/compassionate use programs (EAPs) Support preparation for Regulatory Agency interactions, including scientific advice meetings Review, quality-check, and approve regulatory updates per internal procedures Maintain regulatory systems, databases, and trackers Participate in project team meetings, providing regulatory guidance Identify regulatory gaps and collaborate to implement solutions Maintain compliance with internal Quality Systems and applicable GxP standards Support QA in preparation for regulatory agency inspections Maintain current knowledge of relevant global legislation and guidance (UK, EU, USA, ICH) BASIC QUALIFICATIONS BSc in Pharmacy, Biological Science, or related field Minimum 5 years pharmaceutical drug development experience, including 2 years in regulatory affairs Experience preparing INDs, CTAs, and marketing applications Knowledge of FDA, EU, MHRA, and ICH regulations and guidelines PREFERRED QUALIFICATIONS Strong problem-solving skills and ability to implement solutions Experience supporting regulatory interactions and inspections Knowledge of expanded access/compassionate use program requirements EXPECTATIONS & COMPETENCIES Ability to write, review, and compile regulatory documents including IMPD, IB, eCTD Proficiency with Microsoft Word and Excel OUR VISION We Deliver Novel Therapies That Empower People To Live Better Lives. Our OPERATING PRINCIPLES, referenced below, guide our behaviors and decisions: Define Success – And Then Deliver Act with outcomes in mind. Have high expectations. Details Matter. Be Data Driven And Openly Debate – But Be Decisive Time is valuable. Say the thing you can’t say. Understand timelines and meet them. Have An Ownership Mentality This is your company; treat it that way. Protect our resources, reputation, and results. Be Internally Collaborative And Externally Competitive We go further, faster, together. Have a bias for action, but bring others along. Offer solutions, not just problems. Good People = Great Company Act with integrity. Assume positive intent. Be Kind. 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.