Senior Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Engineer quality processes as a MTO Specialist, driving batch review, leading investigations, and improving operations in a high-quality biopharmaceutical manufacturing environment. Collaborate with t...

Take ownership of regulatory strategy, driving approval for innovative mRNA vaccines. Lead global teams in managing submissions, ensuring compliance, and building relationships with health agencies wh...

Shape the future of regulatory submissions by ensuring high-quality QC reviews of clinical documents. Collaborate with global teams to meet project timelines while maintaining compliance with industry...

Shape the future of regulatory affairs by leading global strategy, ensuring compliance, and fostering key agency relationships. Drive product submissions, build high-performing teams, and enhance orga...

Join a team that's committed to ensuring compliance and accountability in construction by performing detailed audits of payment applications, guiding project owners, and fostering best practices acros...

Engage in the oversight of clinical studies, ensuring compliance and data integrity while collaborating with cross-functional teams and external partners throughout the full study lifecycle for optima...

Seek to advance the future of clean energy by joining a dynamic team focused on the design and analysis of control systems in the power sector. Collaborate on projects that enhance functionality and p...

Join a team that's dedicated to enhancing power plant systems through innovative design and engineering. Collaborate on diverse projects to improve control systems, ensure compliance, and drive client...

Shape global CMC regulatory strategies for innovative cell and gene therapies, driving successful approvals through robust submissions, stakeholder collaboration, and effective risk management to enha...

Accelerate your career by providing engineering support in electric power projects. Collaborate on technical evaluations and conceptual designs, while leveraging your expertise in mechanical systems f...

Transform the release management process by leading cross-functional teams to plan, execute, and govern application deployments in a high-stakes environment, ensuring operational stability and quality...

Oversee and manage clinical trials from protocol development to final report, ensuring compliance with GCP and regulatory standards. Collaborate with cross-functional teams to enhance research efficie...

Join a dynamic team as a Senior Mechanical Project Engineer, leading nuclear plant modifications and engineering projects. Collaborate with multidisciplinary teams, manage project scope, and ensure te...

Lead mechanical engineering efforts for nuclear plant modifications, coordinating multidisciplinary activities and ensuring project execution aligns with technical and safety standards. Collaborate wi...

Reimagine nuclear engineering with cutting-edge design and analysis in power plants, guiding modifications and project teams while ensuring excellence and safety in carbon-free energy solutions...

Collaborate on nuclear power plant systems design, modify operational packages, and conduct engineering evaluations. Lead project teams, interface with clients, and develop cost estimates, ensuring co...

Elevate your career by driving ERP solutions in a remote role while collaborating with cross-functional teams to enhance discrete manufacturing processes and ensure seamless integration and reporting...

Champion innovative solutions as a Senior Systems Analyst driving Infor XA ERP excellence. Collaborate with stakeholders to enhance manufacturing processes through technical and functional expertise...

Lead the charge in establishing a robust Quality Control Program for construction projects, ensuring compliance across MEP trades. Collaborate with diverse teams to drive quality excellence and suppor...

Optimize quality control systems and processes, ensuring compliance with standards while collaborating with engineering and manufacturing teams to enhance product quality and durability. Drive continu...

Elevate product quality by collaborating on evaluation and control systems, driving corrective actions, and implementing rigorous testing. Engage with multifaceted teams to ensure compliance and conti...

Take ownership of quality evaluation and control systems to improve product precision. Collaborate with teams to ensure adherence to quality standards, lead audits, and initiate corrective actions for...

Elevate clinical outcomes by serving as the key pharmacist liaison among partners, translating real-world issues into actionable insights, driving resolution of clinical concerns, and enhancing produc...

Join a forward-thinking team as you shape the future of digital health policy, driving advocacy and collaboration with regulatory authorities while navigating complex medical device standards and AI f...

Manage clinical operations by leading trial planning, vendor oversight, and budget management. Collaborate with cross-functional teams to ensure compliance and drive process improvements while maintai...