Director, Regulatory Affairs Jobs in Waltham, MA

Drive the clinical development of innovative gene therapies, collaborating cross-functionally to design and execute clinical trials while ensuring compliance with regulations and safety practices. Con...

Lead clinical research initiatives in gene therapy, overseeing trial execution and data analysis. Collaborate with internal teams and external stakeholders to drive strategy and ensure compliance with...

Shape the future of global Field Medical excellence by leading strategy development, enhancing MSL capabilities, and fostering collaboration across regions to drive impactful scientific engagement and...

Unlock operational excellence by driving improvements in processes and performance across global operations. Collaborate with plant leaders, leverage technology, and implement structured solutions for...

Drive innovative biotherapeutics through advanced protein design and engineering, utilizing computational methods and data integration. Collaborate across teams to enhance antibody discovery processes...

Join us in overseeing end-to-end clinical supply management for global studies, focusing on demand planning, global distribution, and cross-functional leadership to ensure compliant and cost-effective...

Lead the charge in shaping innovative immunology strategies and external partnerships, driving research-to-development transitions while fostering collaboration across functions to enhance patient out...

Lead the charge in advancing hematology and immunology clinical studies, driving strategy and execution in a collaborative environment. Make an impactful difference in developing therapies for rare di...

Transform medical affairs in immunology by leading strategic initiatives that bridge clinical expertise and scientific communication, fostering collaboration with healthcare professionals and driving...

Accelerate progress at the intersection of healthcare and business by leading a dynamic team focused on delivering innovative solutions and strategic growth, engaging customers and enhancing patient o...

Shape the future of rare neurology by developing innovative outcome measures and evidence generation strategies. Collaborate with cross-functional teams to enhance clinical trial processes and ensure...

Shape the future of immunology by driving strategic initiatives in drug development and external innovation. Collaborate across multidisciplinary teams to advance early clinical development and create...

Manage site operations ensuring efficient flow of information, training, and documentation within clinical research trials while collaborating with multiple departments to enhance trial execution and...

Lead the charge in biostatistical strategies for clinical trials, ensuring high-quality data analysis and regulatory compliance. Collaborate across teams to drive successful drug development initiativ...

Transform the contract lifecycle process by drafting, negotiating, and administering agreements. Collaborate with stakeholders to ensure compliance and clarity in all contractual engagements, while su...

Join a dynamic team focused on monitoring clinical trials, ensuring participant safety and adherence to protocols. Utilize your clinical expertise to uphold data integrity while managing site activiti...

Unlock strategic execution and operational excellence by collaborating across R&D Quality, Audit, and Operational Excellence to drive meaningful initiatives, manage program priorities, and enhance bus...

Drive biopharma market development by translating scientific workflows into strategic, scalable solutions, engaging with senior stakeholders to create high-value opportunities that enhance commercial...

Optimize inventory management and enhance supply chain efficiency while leading a dedicated materials team. Collaborate with cross-functional departments to ensure timely product delivery in a regulat...

Join our Quality Control team to perform essential microbiological analyses, ensuring compliance and data integrity to facilitate the manufacturing of life-changing medicines. Contribute to a culture...

Lead the charge in transforming manufacturing technology through agile program management, driving efficiency and collaboration in advanced global sites while ensuring compliance and operational excel...

Collaborate in a high-growth, cross-functional role to transform ambiguous challenges into strategic outcomes, driving key initiatives that propel company growth and operational excellence...

Shape and enhance the global Quality Management System for medical devices by driving compliance, governance, and continuous improvement while leading a dedicated team across multiple sites to meet re...

Drive legal strategy by managing litigation, regulatory inquiries, and privacy frameworks. Collaborate closely with cross-functional teams while leveraging AI to enhance efficiency. Own projects with...

Drive innovation in clinical evidence management through AI, ensuring high standards and quality control while collaborating with cross-functional teams to enhance data retrieval for regulatory compli...