Regulatory Affairs Manager Jobs in Irvine, CA

Accelerate regulatory compliance and product approvals by leading a skilled team. Collaborate cross-functionally to develop innovative strategies while managing global submissions for advanced ultraso...

Lead global regulatory CMC initiatives for innovative autologous CAR T cell therapies. Drive submissions, lifecycle management, and strategic alignment with market needs across diverse regions, enhanc...

Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...

Grow your career by providing regulatory CMC leadership for global clinical development and commercial expansion in CAR T cell therapy. Engage with cross-functional teams to manage submissions and ens...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Champion compliance and innovation by advising cross-functional teams on FDA advertising regulations, driving strategic decisions to mitigate risks while supporting business objectives in healthcare c...

Lead the charge in shaping global regulatory CMC strategies for CAR T cell therapy, overseeing submissions and lifecycle management, while partnering cross-functionally to drive compliance and innovat...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

Collaborate to lead regulatory projects, ensuring compliance with state and federal standards while enhancing internal processes and fostering strong stakeholder relationships for timely project compl...

Empower progress at the intersection of regulatory affairs and marketing. Lead teams to navigate complex advertising strategies across therapeutic areas while ensuring compliance with industry regulat...

Shape the future of regulatory promotional operations by driving standards and streamlining review processes of promotional materials. Collaborate cross-functionally to ensure compliance and efficacy...

Lead the charge in regulatory strategy for product innovation, ensuring compliance across all markets while collaborating with cross-functional teams to enable fast-paced growth and maintain brand int...

Join a dynamic team as you lead GxP compliance initiatives across global pharmaceutical operations, ensuring adherence to US-FDA regulations. Drive improvements in quality systems and prepare faciliti...

Lead the charge in pioneering advanced nuclear technologies while managing the authorization process for reactor deployment. Collaborate with regulators and technical teams to streamline regulatory su...

Contribute to enterprise leadership in product safety risk management, ensuring compliance and aligned processes throughout the medical imaging software product lifecycle, and leading a team of safety...

Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...

Drive compliance by supporting regulatory affairs for medical devices. Collaborate cross-functionally to manage documentation, ensure audit readiness, and maintain quality systems. This hands-on role...

Shape regulatory strategies for medical devices, leading global initiatives and cross-functional teams to ensure compliance and drive successful submissions while influencing policy at a strategic lev...

Elevate quality standards in dietary supplement manufacturing by overseeing compliance with regulatory requirements, managing QA/QC teams, and ensuring product safety through rigorous testing and insp...

Build impactful relationships with state healthcare regulators to enhance operational efficiency and compliance. Leverage consultative skills to drive multi-year contracts and strategic partnerships...

Contribute to innovative clinical research as a Project Manager managing all aspects of early phase projects, ensuring excellence in execution, compliance, communication, and risk management for succe...