Regulatory jobs in Dover, DE

Job Description Senior Manager, IFX, AIML, & Regulatory Risk - Enterprise Services Risk The Enterprise Services Risk (ESR) organization is expanding with a focus on attracting innovative, pioneering, collaborative, and highly skilled professionals. We operate at the forefront of risk management, providing support for novel and developing technologies, as well as critical business strategies....

Overview Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed...

Job DescriptionAbout the RoleOracle Health Data Intelligence is entering a high-impact phase of MDR (Medical Device Regulation) readiness and regulatory transformation . Over the next year, HDI must execute a large volume of technical documentation, risk management activities, and engineering design updates required for compliance across our AI-enabled population health platform.To support these...

A leading global information services provider in Dover, DE is seeking a Senior Field Sales Executive. This role demands expertise in regulatory compliance and sales acumen to support the sales team and engage with clients effectively. Candidates should have a Bachelor's degree, at least 5 years of experience, and a proven ability to analyze market opportunities. The position offers competitive...

What Regulatory Affairs contributes to Cardinal HealthRegulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing...

A healthcare innovation company based in the United States seeks an experienced regulatory professional to join its team. The successful candidate will author regulatory plans and support submissions for healthcare products, ensuring compliance with FDA and international regulations. They should have over 10 years of experience in regulatory affairs, especially with FDA submissions. The role...

Job DescriptionDigital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes.dCMC intends to deliver:Increased productivity and speed to clinic/marketAccelerated timelines for site, filing, and launch...

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists,...

A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs in Dover, Delaware. This role involves managing regulatory submissions and providing strategic regulatory input for oncology products. Ideal candidates should have a bachelor's degree, substantial experience in the biopharmaceutical industry, and specific experience in regulatory affairs. The position...

Job DescriptionThis role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA, etc.) and guiding cross-functional teams to systematically integrate those requirements into our SDLC and release management practices. You will work to ensure our processes generate the required documentation, evidence, and compliance packages-ready for both internal use and...

Job DescriptionAbout the RoleOracle Health Data Intelligence is entering a high-impact phase of MDR (Medical Device Regulation) readiness and regulatory transformation . Over the next year, HDI must execute a large volume of technical documentation, risk management activities, and engineering design updates required for compliance across our AI-enabled population health platform.To support these...

A global pharmaceutical company is seeking a Vice President of Regulatory Affairs Oncology in Dover, Delaware. This leader will drive regulatory strategy for oncology therapies, leveraging over 15 years of biopharmaceutical experience. Key responsibilities include managing regulatory submissions and ensuring compliance with FDA regulations. The ideal candidate will hold an advanced degree and...

Overview Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.). The company focuses on oncology, urology, women's health, rare diseases, cell & gene therapies and CNS with a diverse pipeline. For more information on SMPA, visit our website or follow us on LinkedIn. Job Overview We are seeking a dynamic, highly...

Job DescriptionOverviewWe are seeking a highly experienced sales and business development professional to drive growth across Commercial, Real-World Evidence (RWE), Clinical, Regulatory, and Safety research services within pharmaceutical and biotechnology organizations. This role is responsible for identifying, developing, and closing complex, large-scale engagements by aligning client needs with...

Job DescriptionOracle Health Data Intelligence (HDI) is building the next generation of intelligent, cloud-based healthcare platforms - combining clinical, payer, and regulatory data at scale to transform how care is delivered and measured. We are bringing hyperscaler technology to healthcare, integrating advanced AI, secure data exchange, and regulatory-compliant infrastructure to accelerate...

Job DescriptionManages the ongoing preparation, testing, and monitoring of compliance with information security standards and government regulations and regulatory agencies as it relates to the design, development, and deployment of products and services. Key Responsibilities:+ Lead, mentor, and grow a team of compliance and security specialists.+ Manage customer engagements focused on compliance...

Job DescriptionAbout the Role:At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations...

Job DescriptionOracle 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 electronic health records (EHR), population health tools, and...

Job DescriptionAssists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies.Responsibilities+ Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and...

Job DescriptionOracle Health Data Intelligence (HDI) is hiring a Principal Technical Program Manager - Operations to lead key strategic and operational initiatives across the organization. This is a highly visible role where you'll report directly to the Director of Operations as a right-hand leader and help scale programs, headcount, tooling, and processes across operations, engineering,...