Regulatory Manager jobs in Anne Arundel County, MD

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....

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,...

If 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 seeking a dedicated and detail-oriented Regulatory CMC Project Manager...

Ready to be pushed beyond what you think you’re capable of?At Coinbase, our mission is to increase economic freedom in the world. It’s a massive, ambitious opportunity that demands the best of us, every day, as we build the emerging onchain platform — and with it, the future global financial system.To achieve our mission, we’re seeking a very specific candidate. We want someone who is passionate...

Job SummaryThe Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) 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 marketing application, post-approval changes, and lifecycle management activities...

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 global pharmaceutical company is seeking a Vice President of Regulatory Affairs Oncology in Annapolis, Maryland. The ideal candidate will have 15 years of biopharmaceutical experience, including specific knowledge of Oncology regulatory submissions. Responsibilities include managing regulatory strategies and interactions, ensuring compliance with FDA regulations, and leading the Regulatory...

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 pioneering healthcare company seeks a Regulatory Affairs professional to strategize and support FDA submissions. You'll manage documentation, ensure compliance, and collaborate with cross-functional teams. This critical role requires a minimum of 10 years in regulatory affairs, experience with international submissions, and an advanced scientific degree. Competitive compensation of $164K to...

A global pharmaceutical company seeks an experienced Associate Director in Regulatory Affairs in Annapolis, Maryland. The ideal candidate will have over 7 years in the biopharmaceutical industry, with at least 4 years in regulatory affairs, particularly in oncology. This role includes leading regulatory strategy, managing submissions, and ensuring compliance with health authorities. Attractive...

A leading global clinical research organization is seeking a detail-oriented Regulatory CMC Project Manager to coordinate regulatory submissions and support global regulatory strategies. The ideal candidate will have over 3 years of experience in regulatory affairs and project management, excellent organizational skills, and the ability to work collaboratively on complex projects. This role is...

Business Analysis Manager - Retail Bank Summary: As a Business Analysis Manager at Capital One, you will apply your strategic and analytical skills to major company challenges. You'll team with world-class professionals to develop and test strategies that ultimately impact the bottom line. And you will do it all in a collaborative environment that values your insight, encourages you to take on...

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...

Join us as a Global Labeling Operations Manager, where you’ll work alongside a large, dedicated client team to drive impactful labeling operations across global markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting...

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...

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. Diverse perspectives...

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 of early‑to‑late‑stage investigational assets, we aim to accelerate discovery,...

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. Diverse perspectives...

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...

We are seeking a motivated Senior / Regulatory Affairs Consultant – Advertising & Promotion to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You’ll play a key role in supporting product...