Director, Regulatory Affairs Jobs in Irvine, CA

Lead the charge in clinical pharmacology strategies for rare disease and oncology programs, driving innovative solutions, study designs, and regulatory interactions to expedite drug development and im...

Unlock potential by leading quality systems and compliance initiatives in a regulated environment. Support product delivery while managing a team to uphold standards and drive continuous improvement a...

Empower your career by leading our Quality Management System and cultivating a quality-centric culture. Collaborate across teams to define standards, manage audits, and support regulatory compliance a...

Lead the charge in developing medical strategy and guiding a regional MSL team, ensuring compliance and advancing clinical practice for improved patient outcomes...

Lead the charge in early clinical development for innovative drug therapies. Collaborate with multidisciplinary teams to advance clinical trials and ensure compliance with industry regulations while d...

Elevate global commercialization strategies for Companion Diagnostic products. Collaborate with cross-functional teams to ensure successful CDx launches while maximizing partner value and driving sust...

Champion impactful litigation and policy strategies to drive innovation and access to medicines. Collaborate with legal and business leaders to navigate the regulatory landscape while managing complex...

Join a dynamic team to lead global marketing initiatives in healthcare, focusing on strategic brand launch, promotional campaigns, and cross-functional collaboration for a first-in-class product, driv...

Lead the charge in global clinical data management strategy and oversight. Drive data integrity, standardize processes, and ensure compliance across all phases of clinical trials, while building a hig...

Join a team that's pivotal in leading downstream process development for biologics. Oversee a talented group of scientists to ensure robust, scalable purification processes while collaborating cross-f...

Take ownership of IT compliance and governance strategies, ensuring enterprise technology platforms meet regulatory standards. Lead risk management and validation programs while collaborating with cro...

Transform how leaders access and understand information by leading the technical vision for BI reporting and analytics. Drive innovation with emerging capabilities like AI, translating business strate...

Drive product excellence by owning the lifecycle and security of high-performance client SaaS platforms hosted on AWS. Lead a dedicated team to optimize operations, ensure compliance, and deliver seam...

Take ownership of a regional marketing strategy to engage healthcare professionals, influencing the adoption of therapies in hematologic malignancies while driving collaboration and insight generation...

Empower cross-functional teams by strategically bridging discovery and clinical development. Lead pharmacology efforts to enhance our pipeline, driving impactful translational science in a collaborati...

Shape the future of clinical trials by managing the execution and oversight of Class III medical device studies. Collaborate with teams and ensure compliance, quality standards, and operational succes...

Lead the charge in project management by ensuring client satisfaction and delivering excellence. Collaborate with teams to streamline processes, prepare reports, and maintain high standards in Pharmac...

Lead the charge in managing the LM drug substance portfolio globally, focusing on commercial tech transfers and supplier relationships. Strategically guide projects to enhance production efficiency an...

Manage a team of medical writers to develop impactful scientific content, ensuring accuracy and compliance. Collaborate with clients and cross-functional teams to drive medical strategies and delivera...

Unlock potential by providing legal guidance for BaaS and payments initiatives, collaborating across teams to translate banking regulations into practical solutions, and ensuring compliance while fost...

Elevate your career as a lead legal advisor for complex commercial contracts, fostering growth in MedSurg operations across the U.S. and Canada while ensuring compliance and strategic alignment with i...

Take ownership of analytical development initiatives, ensuring compliance, accuracy, and high-quality documentation for multiple projects. Collaborate closely with internal teams and external partners...

Elevate patient engagement by leading marketing strategies for MYFEMBREE. Collaborate with cross-functional teams to optimize campaigns across digital, social, and traditional channels, ensuring align...

Contribute to innovative data management solutions in a leadership role, overseeing project timelines and collaborating with global teams. Drive quality and compliance while mentoring peers and ensuri...

Engage in overseeing and enhancing the Medicare Advantage compliance program, ensuring adherence to CMS requirements and federal regulations while collaborating across teams to promote effective compl...