Senior Regulatory Affairs Specialist Jobs in Billerica, MA

Optimize quality oversight of external manufacturing partners while ensuring regulatory compliance and Genetix quality standards. Collaborate across teams to enhance processes in a hybrid environment...

Elevate clinical research by assisting with study design, medical monitoring, and compliance to ensure effective execution of clinical trials and contribute positively to patient outcomes in alignment...

Lead the design and operation of advanced data pipelines and products powering AI in Biopharma. Collaborate with cross-functional teams to streamline data integration, enhance product development, and...

Join a pioneering AI-native team to build and operate cutting-edge data pipelines that empower product development in biopharma, integrating diverse data systems to accelerate safe and effective drug...

Grow your career by leading clinical strategies in a dynamic environment. Drive the design and analysis of clinical studies while collaborating with cross-functional teams to enhance drug development...

Join a dynamic team as a project lead to design, execute, and support biopharmaceutical manufacturing processes. Leverage your expertise to drive technology transfers and ensure compliance while colla...

Drive innovative structural analysis in a collaborative environment, tackling complex mechanical challenges across program phases. Lead technical reviews, generate detailed reports, and ensure complia...

Join a team that's driving packaging innovation in drug product manufacturing. Lead technical strategy and design for late-stage clinical programs, ensuring quality and compliance while collaborating...

Lead the charge in shaping global regulatory strategy and submission planning, ensuring compliance and driving successful outcomes for development-stage indications across the product lifecycle in a d...

Lead the charge in managing complex software programs as a Senior Technical Program Manager. Collaborate across teams, drive alignment, and leverage AI tools to streamline processes and enhance produc...

Champion comprehensive CMC operations in early-phase development, overseeing external manufacturing activities across multiple programs to ensure alignment with quality, cost, and timelines, while opt...

Inspire operational excellence as you manage external development and manufacturing activities in early-phase CMC. Collaborate across functions to ensure quality and timelines while driving efficiency...

Champion the technical support for mammalian manufacturing processes by conducting process transfers and supporting team members. Leverage expertise for process improvement and compliance with regulat...

Transform global key accounts through strategic relationship management, driving growth opportunities and fostering collaboration. Leverage your expertise to enhance customer engagement and deliver ex...

Drive early-stage value creation within Strategic Accounts by building strong R&D relationships, supporting pilot trials, and converting technologies into commercial opportunities. Collaborate with in...

Join a team that's shaping the future of biopharma by driving innovation and collaboration in early-stage R&D partnerships. Cultivate relationships and influence key decisions to enhance technology ad...

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...

Oversee quality assurance efforts by ensuring compliance with cGMPs, managing vendor relationships, performing audits, and supporting regulatory submissions in a dynamic pharmaceutical environment foc...

Contribute to the evolution of maritime credentialing by managing examination content, leading item analysis, and providing expert guidance to ensure regulatory compliance and program effectiveness in...

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

Lead the charge in enhancing quality assurance programs by steering a talented team. Drive AI integration and continuous improvement to ensure accuracy, reduce risks, and optimize client outcomes thro...

Elevate GMP manufacturing processes by developing and transferring radiopharmaceutical technologies. Collaborate with interdisciplinary teams to ensure compliance and advance drug candidates in a fast...

Join a dynamic team to verify FPGA designs for advanced radar applications, ensuring high performance and reliability. Collaborate across engineering disciplines while driving projects from conception...

Explore opportunities as a Senior Electrical Engineer, focusing on FPGA verification for radar applications. Contribute to design success through collaborative efforts in a dynamic engineering environ...

Unlock potential by leading critical acquisition programs, managing execution across the acquisition lifecycle, and coordinating efforts to deliver operational capabilities for the Department of the A...