regulatory affairs assistant jobs in Kent County, DE

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...

Overview Join Parexel as a Post-Approval Regulatory Strategy Lead! Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs? Do you thrive in cross-functional environments and love transforming regulatory requirements into actionable plans? If so, we’d love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy...

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers...

Regulatory Affairs Specialist USThe Regulatory Affairs Specialist US is responsible for preparing, reviewing, and maintaining regulatory submissions and documentation required for U.S. FDA approvals of high-risk and Class III implantable medical devices, including degradable and bioabsorbable implants.The role focuses on ensuring compliance with FDA regulations and supporting product lifecycle...

Overview Position Summary Provides 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 provides an assessment of the associated regulatory...

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...

Environmental Regulatory Affairs Specialist M/F/DJoin to apply for the Environmental Regulatory Affairs Specialist M/F/D role at Agilent Technologies.Job DescriptionInterpret and apply international, federal, state, and local regulations related to the product environmental impact (e.g., Producer Responsibility, WEEE, RoHS, TSCA, REACH).Engage with the Regulatory Intelligence team for product...

Position OverviewThe Regulatory Compliance Manager (Corporate) is a member of the FUJIFILM Holdings America Corporation ("HLUS") Department reporting to the Corporate Compliance Director. The Compliance Manager will be responsible for managing the day-to-day operations of the company's compliance programs related to laws and regulations, including healthcare compliance, anti-corruption,...

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 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...

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 updated regulations and guidance that...

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...

The Director, Strategic Planning & Operations is a pivotal role within the Medical Excellence & Operations team within Global Medical Affairs. This role is responsible for overseeing 3 medical business unit specific Strategic Planning roles (CNS, Nephrology & Immunology, and Rare Disease), as well as one strategic planning role for external engagement. This role will seek to shape and implement...

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...

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 products in...

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 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,...

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 DescriptionModern healthcare demands integrated solutions. At Oracle Health, we connect patients, providers, payers, and public health organizations with AI-powered, interoperable solutions that help streamline data exchange, surface actionable insights, and drive operational efficiencies across the care continuum.As an Interoperability Regulatory Strategist, you will monitor and evaluate...