Regulatory Affairs Specialist Jobs in Irvine, CA

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Join a team that ensures quality oversight in clinical supply, partnering with cross-functional teams and Third Party Manufacturers to maintain compliance and drive continuous improvement in drug deve...

Empower quality assurance excellence by reviewing GMP batch documentation, ensuring compliance for innovative drug substances and products in clinical development. Collaborate globally to maintain sup...

Lead the charge in developing innovative regulatory approaches and managing multidisciplinary projects in California's Central Valley. Collaborate with clients and stakeholders to ensure successful pr...

Lead the charge in shaping and executing the Regulatory Information Management strategy, ensuring data governance and compliance while fostering team development and cross-functional collaboration to...

Unlock potential by leading regulatory submissions strategy and excellence across global clinical trials, ensuring compliance and timely approvals while managing risks and aligning with project teams...

Tackle global regulatory submissions and registrations for medical devices. Bring your expertise to cross-functional teams, ensuring compliance and strategic guidance throughout product development an...

Transform compliance practices by leading structured reviews for federal health programs. Utilize strong judgment and analytical skills to ensure adherence to requirements and maintain documentation...

Architect enterprise-level Direct Materials Certification strategies, ensuring compliance and driving modernization. Influence stakeholders to solve regulatory challenges and enhance supply chain flex...

Join a team that's driving insurance regulatory excellence, leading critical rate-filing activities, and collaborating with diverse teams to ensure compliance. This role offers significant impact in a...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Champion innovative product development by managing clinical usability studies and ensuring compliance with regulatory standards. Collaborate closely with cross-functional teams to drive projects from...

Empower your career by leading clinical usability studies in dental product development, ensuring regulatory compliance, and collaborating across teams to innovate and deliver effective solutions. Mak...

Transform consumer compliance by investigating regulatory disputes, shaping policy, and collaborating across teams to ensure responsible growth and adherence to laws impacting financial operations and...

Shape regulatory strategies for therapeutic neurotoxins in the US & Canada, ensuring compliance with evolving requirements while driving strategic goals. Collaborate with various stakeholders to suppo...

Lead the charge in bridging satellite technology with global regulatory frameworks, shaping policies, and advocating for spectrum assets, while executing strategic initiatives to enhance worldwide con...

Manage key regulatory functions, guiding compliance in PBM, pharmacy, and healthcare technology. Advise on state and federal obligations, and translate regulations into practical strategies for busine...

Advance your career by ensuring compliance in clinical studies, managing site interactions, and driving quality throughout the research process. Collaborate with teams to support study start-up and mo...

Lead regulatory strategies for US & Canada, driving product development and compliance. Collaborate across teams to ensure adherence to health authority standards while mentoring junior staff, influen...

Join a team that drives global regulatory strategy for innovative products. You will lead regulatory affairs for clinical development, ensuring alignment with health authority requirements and facilit...

Drive compliance excellence by overseeing regulatory adherence for complex benefit products. Collaborate with cross-functional teams, conduct risk assessments for innovations, and support escalations...

Drive impactful medical communication strategies by crafting precise scientific content and collaborating with cross-functional teams to meet diverse client needs within a dynamic healthcare landscape...

Advance innovative drug-device combination product development by integrating engineering disciplines to create compliant, patient-focused designs. Collaborate cross-functionally to meet rigorous proj...

Lead the charge in ensuring compliance with banking regulations while managing risk assessments, audits, and policy governance. Collaborate cross-functionally to integrate controls and drive operation...

Unlock potential by leading regulatory strategies in Chemistry, Manufacturing, and Controls. Collaborate across teams to ensure efficient product delivery while fostering relationships with regulatory...