Senior Regulatory Affairs Specialist Jobs in Boston, MA

Lead compliance excellence by conducting quality reviews, enhancing processes, and providing expert guidance to ensure timely, accurate client service and adherence to regulatory standards in a dynami...

Lead the charge in developing global regulatory strategies for innovative immunology programs. Drive product approval processes, ensuring compliance and optimal labeling while managing complex project...

Unlock potential by leading global regulatory strategies for innovative immunology programs. Drive product approval timelines and collaborate with cross-functional teams to ensure compliance and optim...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

Champion the execution of GxP Quality Systems, ensuring compliance and efficiency in document management and training programs while supporting continuous improvement initiatives across various GxP fu...

Join us to enhance quality control processes in a dynamic cGMP laboratory. You'll lead method transfers, train analysts, and ensure compliance while executing critical testing for raw materials and fi...

Join a team that's redefining regulatory compliance in advertising and promotion. This role focuses on DTC communications, ensuring compliance while collaborating with cross-functional teams to enhanc...

Lead complex global regulatory project management activities, ensuring alignment across functions and successful submission milestones. Drive operational excellence and best practices to support a gro...

Champion the U.S. Biologics Regulatory CMC team by providing strategic leadership, ensuring timely regulatory submissions, and fostering collaboration among global stakeholders to drive innovative bio...

Join a dynamic team to deliver strategic CMC regulatory support across diverse therapeutic modalities, ensuring successful clinical trials, market registrations, and compliance. Build collaborative re...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Elevate your career by leading global CMC regulatory strategies for biologics. Collaborate with cross-functional teams, ensure compliance, and drive successful product development while mentoring a hi...

Shape global Regulatory CMC strategies for gene therapy products, ensuring compliance and successful submissions. Collaborate with cross-functional teams to drive projects from clinical trials to comm...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Lead the charge in ensuring quality control through hands-on testing, method transfers, and training in a cGMP laboratory. Collaborate across teams to enhance technical capabilities and maintain compl...

Join a team that's dedicated to ensuring quality through hands-on testing and method development. Collaborate across departments to enhance laboratory capabilities and train analysts, all while mainta...

Lead impactful QA/RA initiatives to enhance compliance and quality systems for medical device clients. Drive innovative strategies using AI technology to shape the future of regulatory affairs and ens...

Elevate your career by leading CMC Regulatory strategy and execution. Drive submissions, build a high-performing team, and engage with global health authorities to ensure compliance and success in dru...

Lead the charge in managing CDMO vendor relationships while ensuring seamless logistics, performance tracking, and communication across drug substance programs. Drive operational excellence and elevat...

Develop and execute strategies for managing reference materials and assay controls, ensuring compliance with cGMP standards. Collaborate with cross-functional teams to support clinical and commercial...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Drive regulatory CMC strategy and execution for biologics programs, ensuring high-quality submissions and compliance with global standards. Collaborate across teams to guide development strategy and i...

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

Join a dynamic team to shape regulatory capability strategies, ensuring alignment across business and technology. Drive enhancements in regulatory systems, optimize processes, and support cross-functi...

Drive regulatory capability strategy by collaborating with cross-functional teams to translate needs into scalable system solutions, enhancing compliance and efficiency across business processes and t...