Senior Regulatory Affairs Specialist Jobs in Madison, NJ

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Drive strategic regulatory initiatives and ensure global compliance for oncology programs, navigating complex agency interactions, and securing market approvals for innovative mRNA therapeutics. Lead...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

Lead the charge in global post-market surveillance by overseeing deliverables, providing team leadership, and ensuring regulatory compliance for medical devices. Engage in strategy, analysis, and cros...

Lead the site sterility assurance program, optimizing compliance with regulations and manufacturing best practices, while collaborating cross-functionally to protect product quality and patient safety...

Join a team that's pivotal in ensuring regulatory compliance for promotional activities across our oncology portfolio. This strategic role collaborates with cross-functional teams to maintain complian...

Drive regulatory leadership for early-stage drug development with cross-functional collaboration, supporting strategic business decisions and ensuring strong regulatory alignment throughout product li...

Lead the charge in ensuring continuous regulatory compliance and inspection readiness for R&D technology solutions by executing audit readiness strategies, embedding GxP compliance, and collaborating...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Transform the client onboarding experience as a Senior AR Specialist. Engage directly with new clients, optimize workflows, and refine our AI tools through real-world testing, ensuring a seamless tran...

Drive innovation as a leader in regulatory data governance, overseeing a global team to ensure high-quality data aligns with strategic business goals while fostering cross-functional collaboration and...

Oversee a global data stewardship team, ensuring high-quality regulatory data for analytics and decision-making. Lead data governance initiatives and collaborate across sectors to enhance foundation f...

Innovate regulatory strategies to accelerate product development, ensuring compliance and market readiness through expert guidance and cross-functional collaboration, while managing risks and opportun...

Drive global regulatory strategies for pharmaceutical development programs, ensuring compliance and effective submissions. Lead cross-functional teams and navigate complex regulatory landscapes to ach...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Shape the future of patient access by leading regulatory strategies that empower pharmaceutical and biotechnology sponsors to explore innovative pathways and solutions for investigational therapies, e...

Join a team that's dedicated to advancing clinical trials and ensuring smooth study operations by collaborating across functions, supporting trial execution, and maintaining strong communication with...

Lead the charge in supporting clinical study teams with administrative and technical expertise, ensuring trials progress efficiently from activation through close-out while fostering collaboration acr...

Unlock potential by providing essential technical and administrative support for clinical trials, ensuring timely execution from activation to close-out while collaborating with diverse teams and mana...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Accelerate clinical trial success by optimizing monitoring strategies and processes for efficient, quality data management in alignment with regulatory standards and timelines...

Elevate sterility assurance and contamination control strategies globally. Lead risk assessments and foster best practices across our sterile manufacturing sites while championing continuous improveme...

Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...

Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...