Director, Regulatory Affairs Jobs in Irvine, CA

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...

Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...

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...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

Join us in driving operational excellence in regulatory submissions and document workflows. Lead cross-functional teams to ensure compliance and quality across all submissions while optimizing process...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Lead the charge in driving global regulatory strategy for a vital product portfolio. Collaborate with cross-functional teams to ensure compliance and innovation, shaping strategies that influence busi...

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...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

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...

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

Unlock potential by leading global quality compliance for pharmaceutical products. Drive audit excellence, manage inspection readiness, and partner with teams to ensure adherence to regulations while...

Shape the future of global regulatory strategy for biologics by leading negotiations, driving approvals, and influencing cross-functional partnerships across multiple markets, ensuring compliance and...

Play a key role in developing and executing regulatory strategies, ensuring compliance for clinical trials and marketing applications, while leading cross-functional teams to manage project timelines...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

Shape complex CMC regulatory strategies for innovative cell therapy products, ensuring compliance, timely submissions, and high-quality deliverables while collaborating across diverse teams in a dynam...

Lead the charge in driving complex CMC regulatory activities for cell therapy products, enhancing global strategies and ensuring compliant submissions while collaborating with cross-functional teams t...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...

Shape the future of compliance by leading a team in navigating complex regulatory frameworks. Ensure operational excellence while driving high performance in regulatory affairs, partnering with key st...

Lead the charge in effective regulatory compliance by overseeing a dedicated team, ensuring adherence to CMS and state regulations while fostering a culture of excellence in managed care operations an...