Global Regulatory Lead

A global biopharmaceutical company in Honolulu is seeking a Senior/Consultant, Regulatory Labeling to lead global labeling efforts and ensure compliance with regulations. You will collaborate with cross-functional teams and drive improvements in labeling strategies. The ideal candidate has at least 4 years of relevant experience and strong attention to...

A global pharmaceutical company in Honolulu is seeking an experienced Associate Director of Regulatory Affairs to lead regulatory strategy for various projects. The ideal candidate will have extensive experience in the biopharmaceutical industry, especially in regulatory affairs, along with a Master's degree. This role emphasizes strong communication skills...

Global Regulatory Affairs SpecialistProvides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and...

Chemistry, Manufacturing and Controls Global Regulatory AffairsThe Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial...

Lead Product Regulatory StrategistOracle Health is a comprehensive suite of healthcare technology solutions designed to help organizations advance patient care, improve operational efficiency, and enhance caregiver experiences. Building on Oracle's global expertise in cloud technology, data management, and analytics, Oracle Health delivers integrated...

A leading pharmaceutical company in Hawaii is seeking an Associate Director of Regulatory Intelligence to lead the collection and analysis of regulatory intelligence. The role requires overseeing regulatory updates, managing a team, and ensuring compliance within the pharmaceutical environment. Ideal candidates will have a Master's degree and extensive...

Associate Director, Regulatory Affairs (Oncology)Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline...

Regulatory Cmc Project ManagerIf you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently...

Sumitomo Pharma Co., is a global pharmaceutical company based in Japan with operations in the U.Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to...

The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. Job Description Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and...