Kalvista Pharmaceuticals INC jobs

Regulatory Affairs Manager Sailsbury, UK 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

Associate Director, Regulatory Affairs Salisbury, UK 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 Associate Director, Regulatory Affairs will join the Regulatory Development team at KalVista in contributing to the development of regulatory submissions in alignment with company objectives and support the successful commercialization of KalVista'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. RESPONSIBILITIES 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 KalVista's Regulatory Intelligence process Maintain compliance with KalVista's Quality Management System

Associate Director, Commercial Supply Planning Framingham, US 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 KalVista seeks a highly motivated and knowledgeable professional to join us as Associate Director, Commercial Supply Planning. Reporting to the Senior Director, Supply Planning and Network Strategy, this role will lead supply planning activities for both US and Global Commercial programs. As a key member of the planning team, you will develop an all-encompassing strategy focusing on New Product Introduction (NPI) to lifecycle management of all marketed products at KalVista. This role will also place a high emphasis on planning in an ERP environment (SAP), along with reporting the “health” of our supply chain through generation of robust metrics and KPIs. Our ideal candidate will possess a strong skillset required to translate fluid forecasts into working production plans, pre and post launch activities and aligning cross functionally in execution of product to patient. RESPONSIBILITIES Maintain target level of end-to-end supply across all regions. Ensure demand and supply are accurately reflected and executed in SAP Oversee the Supply

Senior Medical Director, Asset Lead – Oncology (Neuroendocrine Tumors / Carcinoid Syndrome) Remote Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others. POSITION SUMMARY: Crinetics is seeking an experienced oncology Medical Affairs leader to serve as Senior Medical Director, Asset Lead - Oncology (Neuroendocrine Tumors / Carcinoid Syndrome), reporting to the Executive Director, Medical Affairs. This role will provide Medical Affairs leadership for a complex oncology program within the Neuroendocrine Tumor (NET) landscape, requiring deep expertise in oncology clinical development, competitive data interpretation, and cross functional medical strategy. This individual will be responsible for shaping and executing Medical Affairs strategy across evidence generation, scientific exchange, and KOL engagement, ensuring alignment with Clinical Development, Regulatory, Commercial, Market Access, Compliance, and Legal functions. The role demands strong scientific credibility in oncology, the ability to interpret and translate complex oncology data, and comfort

Werkstudent (m/w/d) Pharmaceutical Technical Solutions DEU - Niedersachsen - Friesoythe posted: Posted 30+ Days Ago

Pharmaceutical Manufacturer Relations Executive Remote Nationwide posted: Posted 2 Days Ago

Asso. Pharmaceutical Information Manager, Onco CHN - Guangdong - Foshan posted: Posted 15 Days Ago

Pharmaceutical Information Specialist,AI CHN - Shanghai - Shanghai (Tower A) posted: Posted 7 Days Ago

Sr. Pharmaceutical Info Specialist CHN - Shanghai - Shanghai (Tower A) posted: Posted 22 Days Ago

Sr. Pharmaceutical Info Specialist, Onco CHN - Shandong - Yantai posted: Posted 11 Days Ago

Sr. Pharmaceutical Info Specialist,AI CHN - Jiangsu - Suzhou posted: Posted 30+ Days Ago

Pharmaceutical Information Manager CHN - Shanghai - Shanghai (Trading) posted: Posted 8 Days Ago

Scientist, Pharmaceutical Analytical Sciences USA - New Jersey - Rahway posted: Posted 10 Days Ago

Pharmaceutical Information Specialist CHN - Shanghai - Shanghai (Tower A) posted: Posted 7 Days Ago

Pharmaceutical Production Lead - All Shifts Waukegan, Illinois posted: Posted 29 Days Ago

Director, Pharmaceutical Analytical Sciences USA - New Jersey - Rahway posted: Posted 29 Days Ago

Vice President, Pharmaceutical Development Watertown, MA Who we are: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn . How we work: - PIONEER : We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines. - COLLABORATE : We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine. - BELONG : We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard. How you'll make an impact: - Define and lead the company's pharmaceutical development strategy across the portfolio, ensuring alignment with corporate priorities and development timelines - Provide strategic leadership for preformulation, biopharmaceutics, and formulation development activities supporting discovery, preclinical, and clinical-stage programs - Champion innovation in formulation sciences and enabling technologies to

Pharmaceutical Product Operator - All Shifts Waukegan, Illinois posted: Posted 29 Days Ago

Pharmaceutical Production Technician - All Shifts Waukegan, Illinois posted: Posted 29 Days Ago

Vice President, Marketing Watertown, MA Who we are: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn . How we work: - PIONEER : We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines. - COLLABORATE : We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine. - BELONG : We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard. How you'll make an impact: As we prepare for the potential launch of KT-621, a novel oral protein degrader being developed for immune-mediated diseases, we are seeking an experienced and strategic leader to prepare the organization for Kymera's first commercial launch. The position will be responsible for leading commercial strategy, launch readiness, and

Vice President - Pricing & Market Access Watertown, MA Who we are: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn . How we work: - PIONEER : We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines. - COLLABORATE : We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine. - BELONG : We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard. How you'll make an impact: The Head of Pricing & Market Access will lead global and U.S. pricing, reimbursement, access, and value strategies across Kymera's pipeline and future commercial products. Reporting to the Chief Commercial Officer, this executive will play a critical role in maximizing patient access and commercial

Associate Director, Biostatistics Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! As an Associate Director, Biostatistics this person will provide statistical support for pipeline compounds' clinical development, regulatory filing, and commercialization. Reporting to Vice President, Head of Biometrics and Data Science, the successful candidate will serve as the biostatistician for assigned clinical trials to provide statistical leadership from trial design, data analysis, to results interpretation and dissemination. This role will also provide statistical support to regulatory filing

Senior Medical Director Clinical Development Neuroscience Remote, Hybrid, New Haven - CT Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-102, targeting LRRK2 for neurodegenerative diseases; ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic, colorectal, and non-small cell lung cancers; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle; and vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer. On August 8 th 2025, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor degrader- for its use as a monotherapy in the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant. In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development

Senior Director, Clinical Development Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! The Sr. Director, Clinical Development will play a key role in the design and execution of ongoing and new clinical studies and contribute to the clinical development plan for one or more programs. The position will successfully lead and/or serve as the clinical science representative on one or more clinical studies (US and/or global) to deliver high quality data for registration. The position requires the