Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Champion regulatory excellence by leading CMC strategies for small molecule programs, ensuring compliance and driving successful submissions from early development through commercialization in a dynam...

Lead regulatory operations by overseeing submissions, enhancing processes, and mentoring the team. Ensure compliance and accuracy while managing multiple priorities in a dynamic, remote environment. D...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Lead compliance excellence by conducting quality reviews, enhancing processes, and providing expert guidance to ensure timely, accurate client service and adherence to regulatory standards in a dynami...

Lead the charge in regulatory strategy for advertising and promotion in immunology. Collaborate with cross-functional teams to drive initiatives, analyze market trends, and enhance processes while ens...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

Build and lead the Supplier Quality organization, ensuring external suppliers meet quality, engineering, and regulatory standards as the company transitions from prototype to commercial operations, fo...

Lead regulatory strategies for T-cell and LVV products, ensuring compliance and quality across all development stages. Collaborate with cross-functional teams to drive submissions and support manufact...

Join a team that's shaping the future of oncology advertising and promotion. Lead cross-functional initiatives, drive strategic decisions, and leverage industry knowledge to enhance business opportuni...

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...

Elevate your career by leading global CMC regulatory strategies for biologics. Collaborate with cross-functional teams, ensure compliance, and drive successful product development while mentoring a hi...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Elevate your career by leading CMC Regulatory strategy and execution. Drive submissions, build a high-performing team, and engage with global health authorities to ensure compliance and success in dru...

Shape the future of product quality by providing expert guidance in quality engineering for New Product Introduction and Life Cycle Management, ensuring compliance with regulatory standards and drivin...

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...

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

Drive regulatory CMC leadership for global CAR T cell therapy, ensuring compliance and alignment with business objectives. Collaborate with cross-functional teams to manage submissions and lifecycle s...

Unlock potential by leading global regulatory CMC efforts for CAR T cell therapies. Collaborate with cross-functional teams to ensure compliance and drive successful submissions, lifecycle management...

Unlock potential by driving supplier compliance and continuous improvement. Collaborate with cross-functional teams to ensure quality standards and regulatory requirements are met, while managing supp...

Drive the procurement and validation of Measurement and Test Equipment, ensuring compliance with industry standards. Collaborate with teams to analyze data, maintain documentation, and provide trainin...

Drive quality excellence in new product introductions, ensuring compliance and efficiency through risk management, validation, and cross-functional collaboration in a regulated environment...

Transform healthcare engagement by building relationships with HCPs through digital interactions and telephone conversations, promoting products, and achieving sales goals while ensuring compliance wi...

Champion the delivery of clinical studies by monitoring site performance, ensuring compliance, and collaborating with local teams to achieve study milestones efficiently and effectively...

Innovate regulatory compliance and product safety strategies while managing labeling and documentation for food products. Collaborate across departments to minimize risks and ensure adherence to evolv...

Join a team that's shaping regulatory strategies for advertising and promotion. Leverage your expertise to ensure compliance while collaborating with cross-functional teams to drive impactful product...