Director, Regulatory Affairs Jobs in Irvine, CA

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 development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

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

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

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

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

Unlock potential by leading regulatory strategy for clinical gene therapy programs. This execution-focused role drives submissions and health authority interactions while collaborating across cross-fu...

Drive your career forward by leading regulatory labeling and compliance strategies in a dynamic role that collaborates across teams to ensure successful product lifecycle management and adherence to i...

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...

Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...

Join a team that's dedicated to ensuring regulatory compliance for medical devices. In this role, you'll manage domestic and international filings, collaborate with regulatory teams, and support produ...

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

Reimagine global regulatory strategy for cell therapies, leading complex programs from development to approval. Collaborate with cross-functional teams, drive Health Authority engagements, and mentor...

Lead the global GMP/GDP audit organization, enhancing predictive compliance intelligence while mitigating risks through advanced analytics and effective audit strategies...

Transform the regulatory landscape by leading labeling efforts for animal health products, ensuring compliance and excellence throughout the product lifecycle while collaborating with cross-functional...

Transform quality governance across R&D initiatives by leading strategic reviews, optimizing compliance, and enhancing decision-making insights. Collaborate with cross-functional teams to ensure disci...

Join a dedicated team driving global regulatory strategy for early-stage oncology products. You'll execute and manage high-quality submissions and collaborate across functions to ensure compliance and...

Lead compliance initiatives by developing and maintaining product labeling that meets FDA and international regulations, while collaborating with cross-functional teams to support innovation and growt...

Join a dynamic team driving global regulatory strategy, fostering collaboration across regions and units to enhance compliance and market access while leading a diverse regulatory talent pool to eleva...

Transform regulatory compliance by supporting submissions and documentation, ensuring adherence to standards, and collaborating with teams to navigate evolving regulations in a dynamic environment...

Empower global market growth by leading regulatory strategies for companion diagnostics. Collaborate with cross-functional teams and ensure compliance with various regulatory submissions while managin...

Champion global regulatory strategies by leading diverse teams in navigating complex approval processes for medical devices. Drive compliance and ensure optimal product launch pathways while addressin...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Unlock potential by leading a global trade compliance program that ensures adherence to international laws while optimizing product flow across the pharmaceutical supply chain. Collaborate with Legal...

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...