Director, Regulatory Affairs Jobs in Irvine, CA

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

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...

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...

Champion regulatory excellence by guiding project teams, developing global strategies, managing submissions, and ensuring compliance with FDA and international regulations while navigating complex env...

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...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

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...

Lead regulatory support for Neurology and Oncology agents, driving strategies and submissions for global approvals. Collaborate across teams to enhance development timelines and ensure compliance with...

Oversee regulatory strategies for Neurology and Oncology product registrations, ensuring compliance and successful interactions with health authorities. Provide support across product lifecycles, enha...

Optimize regulatory strategies and compliance globally by leading cross-functional projects, guiding teams, and liaising with health authorities throughout the drug development lifecycle to ensure suc...

Drive regulatory excellence by managing submissions, guiding teams, and ensuring compliance. Utilize your expertise to support global projects and foster collaboration in a fast-paced environment focu...

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...

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...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Unlock potential by leading comprehensive quality assurance programs for supplier management, internal audits, and GMP training. Drive compliance and maintain high standards in a dynamic biopharmaceut...

Drive regulatory strategies and oversee compliance for investigational therapies. Work cross-functionally to ensure timely regulatory filings and maintain vendor relationships, contributing to clinica...

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

Join a pioneering team transforming cardiovascular care through AI. Lead regulatory strategies and drive international expansion for innovative medical devices in clinical and veterinary markets, ensu...

Drive global CMC strategy for transformative cell and gene therapies, ensuring seamless regulatory pathways and efficient product approvals through collaborative leadership and strategic risk manageme...

Champion excellence in clinical trial management, ensuring compliance with Good Clinical Practices and product lifecycle regulations. Lead strategic initiatives and multiple teams toward achieving qua...

Drive operational excellence by managing regulatory affairs processes and supporting scalable promotional material reviews. Collaborate cross-functionally to enhance compliance, training, and automati...

Drive global regulatory labeling initiatives, ensuring compliance and quality of documentation across diverse markets. Lead strategic governance, influence policies, and collaborate cross-functionally...

Drive regulatory excellence by overseeing complex projects, ensuring timely submissions and compliance. Lead analytics and strategy teams to optimize processes and outcomes while contributing to innov...