Director, Regulatory Affairs Jobs in Irvine, CA

Grow your career with a leading team in Regulatory Affairs, developing and implementing strategies for global commercialization of medical devices while ensuring compliance with regulations and foster...

Unlock the power of regulatory insights! Lead comprehensive monitoring and analysis of regulatory developments, providing actionable intelligence to guide business strategy and decision-making across...

Lead the charge in global regulatory strategies for innovative medical devices, driving project success from registration to compliance. Collaborate across teams to enhance healthcare technologies and...

Join a team that's shaping the future of biotech by leading quality assurance strategies. Drive compliance and build scalable systems to support NDA submissions and seamless commercial launches while...

Join a team that's driving innovation in commercial growth, leading a dynamic group of sales specialists. You'll craft strategies that impact business revenue, foster talent, and enhance customer enga...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...

Champion innovative access solutions by driving relationships with national payers and clients. Lead strategies that maximize patient access and profitability while collaborating with cross-functional...

Engage with key stakeholders to develop and lead strategic policy initiatives that drive Travere Therapeutics' mission in rare disease advocacy and legislation. Collaborate cross-functionally to influ...

Join us in building a comprehensive compliance program that drives integrity and accountability as we transition into a commercial organization, ensuring adherence to regulatory standards and supporti...

Join a dynamic team as you lead regulatory compliance initiatives, collaborating across departments to navigate complex medical device regulations. Your expertise will ensure product safety and effica...

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...

Unlock potential by leading trade strategy development and distribution optimization for a pioneering biopharmaceutical. Drive partnerships, manage logistics, and ensure compliance to enhance product...

Transform chronic weight management strategies on a global scale, driving evidence generation and medical communication while leading cross-functional collaboration to deliver impactful healthcare sol...

Lead the charge in advancing quality assurance for cutting-edge radiopharmaceuticals. Oversee development quality, regulatory compliance, and team leadership, ensuring alignment with GMP and enhancing...

Join a dynamic team to lead clinical studies, ensuring strategic execution and oversight in neuropsychiatric drug development. Drive collaboration across departments and contribute to regulatory frame...

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

Drive access to innovative therapies while collaborating with cross-functional teams to enhance patient support. This role focuses on navigating the reimbursement landscape and educating healthcare pr...

Drive regulatory compliance by preparing FDA submissions, maintaining global registrations, and collaborating with technical teams. Guide audits and develop SOPs to ensure product quality and adherenc...

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

Champion business growth by overseeing client relationships and sales strategies. Engage with key accounts, analyze opportunities, and lead the sales process to drive success in the healthcare sector...

Drive R&D quality and compliance by partnering with teams to ensure adherence to regulations. Lead audits, manage CAPAs, and support inspection readiness to maintain high standards within the research...

Drive compliance and quality assurance in R&D by leading audits, managing CAPAs, and partnering cross-functionally. Enhance GCP and GVP oversight to ensure alignment with regulations and internal qual...

Lead the charge in GMP API Quality Assurance, overseeing compliance and performance management with external manufacturers. Collaborate cross-functionally to ensure inspection readiness and support a...

Shape the future of vascular solutions by leading regulatory strategies for endovascular medical devices. Contribute to product lifecycle management and partner with cross-functional teams to ensure c...

Shape and lead global strategic alliances, fostering growth through executive relationships, driving revenue generation, and overseeing a dynamic portfolio of partners while implementing best practice...