Regulatory Affairs Specialist Jobs in Irvine, CA

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...

Join a team that's at the forefront of developing regulatory strategies for medical devices. Drive global compliance and foster a culture of regulatory excellence while collaborating with diverse team...

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

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...

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

Empower quality assurance initiatives by collaborating across functions to enhance GMP systems, ensure compliance, and lead process improvements while providing technical expertise and guidance for do...

Drive quality excellence by leading QMS activities and continuous improvement initiatives. Collaborate cross-functionally to maintain compliance and enhance quality systems, ensuring a robust QMS fram...

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

Transform the landscape of regulatory advertising in eye care by leading cross-functional teams, strategizing complex initiatives, and analyzing industry trends to drive successful outcomes and foster...

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...

Shape the future of biopharmaceutical engineering by leading qualification processes, guiding teams, and ensuring compliance with cGMP standards while developing innovative solutions for complex biopr...

Transform the quality landscape as a key contributor to our QA team! Drive improvements in GMP documentation, lead audits, and enhance quality systems. Collaborate cross-functionally to elevate compli...

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...

Lead the charge in clinical research by monitoring studies across various therapeutic areas, ensuring top-quality standards and effective communication with stakeholders while driving project timeline...

Help us drive excellence in clinical research by monitoring studies across various therapeutic areas, enhancing collaboration with project teams and trial sites, and ensuring adherence to the highest...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

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...

Analyze and enhance Environmental Health and Safety programs in compliance with FDA regulations, focusing on risk assessments, training, and incident management to foster a safe workplace environment...

Advance your career by managing quality systems in a regulated medical-device environment. You will lead CAPA and nonconformance investigations, ensuring compliance and effective collaboration with va...

Innovate with a Quality Systems Engineer to enhance quality system activities in a regulated medical-device setting, driving compliance and process improvement through structured investigations and cr...

Elevate quality assurance standards by implementing improvements, conducting audits, and ensuring GMP compliance. Collaborate across teams to enhance processes and lead initiatives that foster a cultu...

Join a team that's driving compliance excellence in supply chain operations. This role blends collaboration across Contracts, Legal, and Supply Chain, focusing on government contracting and ensuring r...

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...