Director, Regulatory Affairs Jobs in Gaithersburg, MD

Shape the future of reimbursement project assessments by leading technical reviews, guiding analysts, and establishing impactful frameworks, standards, and processes. Collaborate cross-functionally to...

Champion analytical lifecycle management for commercial products globally, ensuring compliance and harmonization. Lead investigations, oversee QC networks, and drive continuous improvement while manag...

Shape labelling strategies in oncology by leading a global team, ensuring compliance while collaborating with R&D stakeholders to enhance patient care and product success through innovative regulatory...

Champion the growth of our partner state regulatory agencies by fostering trust and delivering strategic solutions. This role demands patience and expertise in navigating complex government environmen...

Shape the future of oncology market access by leading pricing strategies, optimizing gross-to-net performance, and ensuring regulatory compliance while guiding a dedicated team to excel in a high-scru...

Join a team that's advancing healthcare by owning the Quality Management System for a regulated medical device program, driving design controls, V&V strategies, and risk management while ensuring comp...

Engage with us to build and manage a robust government sales pipeline, driving opportunities from initial identification to close. Shape strategies and foster relationships across DoD and DHS as you l...

Grow your career with a dynamic role leading regulatory strategies globally. Shape innovative solutions for complex projects in pharmaceutical development, ensuring compliance while guiding cross-func...

Join a team that's driving innovation in automation strategy for U.S. growth projects. Lead cross-functional initiatives in a dynamic environment, ensuring reliable, compliant systems for small molecu...

Transform the automation strategy for GMP manufacturing, leading projects from design to operational handover. Collaborate cross-functionally to ensure compliance and scalability in drug substance pro...

Champion strategic litigation and policy initiatives that shape drug pricing and access to optimize patient care within a dynamic regulatory landscape. Collaborate with cross-functional teams to advan...

Lead and optimize global clinical data management operations, ensuring the delivery of high-quality, compliant datasets throughout clinical trials. Drive innovation and data governance, mentoring team...

Lead the strategic direction and operations of the Specialty Testing division, driving innovation and partnerships to enhance clinical research and patient outcomes globally while collaborating with i...

Join a team that's redefining Specialty Testing through strategic leadership, innovative development, and impactful partnerships to enhance patient outcomes worldwide. Drive collaboration and shape th...

Drive the strategic vision for Specialty Testing, overseeing product and clinical research, and leading collaborations to enhance patient outcomes while ensuring compliance and optimizing product deve...

Join a team that's shaping the future of Specialty Testing through innovative strategies in clinical and product development, while ensuring optimal patient outcomes on a global scale. Collaborate wit...

Drive strategic vision and daily operations for Specialty Testing, enhancing product development and market presence while ensuring compliance and quality. Lead collaborations to optimize clinical inn...

Engage with cross-functional teams to set strategic direction and drive the Specialty Testing business, enhancing patient outcomes through innovative product development and clinical engagement with e...

Lead the strategic direction and daily operations for Specialty Testing, influencing product development and clinical research. Collaborate across teams and engage with external stakeholders to enhanc...

Innovate your career by leading technology strategy for a portfolio of products. Collaborate with cross-functional teams to deliver scalable solutions that enhance commercial operations and drive busi...

Empower compliance excellence by leading cross-functional initiatives to ensure adherence to national security regulations. Collaborate with diverse teams to manage compliance processes and audits eff...

Explore impactful opportunities to drive health system adoption of innovative diagnostics, building strategic relationships while leading expansion efforts, managing complex contracts, and orchestrati...

Grow your career with us by providing expert guidance in developmental and reproductive toxicology, shaping strategies across diverse drug development projects, and influencing teams to ensure safety...

Join a team that's shaping the future of clinical trials by driving operational strategies and ensuring successful study delivery, impacting lives through innovative neurological research in a flexibl...

Optimize the impact of medical writing by leading complex projects, managing teams, and ensuring compliance with regulatory standards, while contributing to the strategic growth of the organization in...