Regulatory Affairs Specialist Jobs in Irvine, CA

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

Empower global labeling excellence by managing regulatory compliance, overseeing document governance, and collaborating with cross-functional teams to ensure safe and effective use of innovative medic...

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 shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

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...

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...

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...

Advance quality standards by providing real-time QA oversight during manufacturing operations, ensuring compliance with cGMP and regulatory requirements while driving quality decision-making in a dyna...

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...

Champion global regulatory excellence by navigating diverse pathways for safe product registration. Collaborate with cross-functional teams, ensure compliance, and influence international healthcare o...

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

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...

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...

Lead regulatory strategy for innovative medical devices, ensuring compliance and facilitating global submissions. Collaborate with cross-functional teams and drive strategic initiatives to support the...

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...

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

Support the Quality Management System by reviewing and approving key documentation, ensuring compliance with regulations. Champion best practices in discrepancy reporting and CAPA processes while coll...

Lead NERC CIP compliance initiatives, ensuring audit readiness and cross-functional collaboration. Drive modernization and improvement efforts to safeguard regulatory performance in transmission and d...

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...

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

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...