Director, Regulatory Affairs Jobs in Irving, TX

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...

Unlock potential by driving strategic engagement initiatives within the urology and oncology sectors through collaborative relationships with key opinion leaders and stakeholders, enhancing patient ac...

Champion quality assurance and compliance in R&D for surgical ophthalmic devices, driving innovation and ensuring regulatory standards while managing projects and resources independently to enhance pr...

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...

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...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Shape the future of quality management by leading global strategies, driving compliance, and fostering a high-performance culture. Collaborate with cross-functional teams to ensure top-tier quality st...

Empower the execution of CMC strategies by collaborating across teams to enhance production, streamline operations, and drive commercial success for innovative therapeutics and diagnostics, ensuring a...

Drive regulatory strategy by collaborating cross-functionally to influence promotional activities, ensuring compliance while optimizing risk management for impactful business decisions across a dedica...

Optimize regulatory strategies for robotic surgical instruments, ensuring compliance and market access. Lead cross-functional teams, prepare vital submissions, and drive innovative product development...

Unlock potential as you drive US market access strategy, ensuring effective payer and provider engagement while leading reimbursement initiatives and enhancing patient access outcomes across the healt...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Elevate your career by driving payer engagement and market access strategies in the healthcare sector. You'll engage stakeholders, influence medical policy, and expand reimbursement pathways, all whil...

Drive strategic payer engagement by expanding medical policy coverage and enhancing reimbursement access. Shape relationships with key stakeholders to achieve commercial success in an evolving healthc...

Drive innovative access strategies for oncology diagnostics, shaping payer engagements to enhance patient adoption and reimbursement efficacy globally. Collaborate with cross-functional teams to integ...

Drive regulatory excellence by managing compliance for Phase 2-4 clinical trials. Collaborate with stakeholders, mentor teams, and enhance processes to ensure research integrity and operational succes...

Join a dynamic team to drive manufacturing and operational plans ensuring compliance, quality, and efficiency for commercial and clinical products. Collaborate with leadership to improve processes and...

Innovate global communications strategies for obesity treatments by partnering with diverse teams, driving impactful narratives, and executing plans that enhance development and launch. This role requ...

Champion global supply chain excellence by driving master data strategy and governance initiatives. Influence enterprise strategies while collaborating closely with cross-functional leaders to ensure...

Lead data governance and FAIR practices to drive analytics, AI innovation, and data strategy across the enterprise. Collaborate with cross-functional teams to establish scalable data management framew...

Shape the future of U.S. trade and distribution; lead strategy, operationalize models, and build partnerships to ensure smooth commercial launches and product availability across diverse channels in a...

Help us shape the future of clinical trials by providing regulatory guidance and maintaining compliance. Collaborate within cross-functional teams to ensure successful submissions and uphold industry...

Unlock potential in regulatory affairs by steering clinical trial submissions, ensuring compliance and strategic oversight. Collaborate with project teams, advising on regulatory pathways for successf...