Senior Regulatory Affairs Specialist Jobs in Cambridge, MA

Explore a role that leads LNP and formulation operations, ensuring quality and rapid delivery across biopharmaceutical development while fostering collaboration and innovation in a dynamic environment...

Engage in cross-functional support for GxP activities, leading eQMS optimization and quality process improvement initiatives to ensure compliance and inspection readiness. Become a subject matter expe...

Unlock sustainable solutions by leading environmental site assessments and remediation projects across New England. Collaborate with stakeholders to ensure compliance and drive meaningful change in co...

Lead sustainable environmental practices as a Massachusetts LSP, managing site investigations and remediation. Collaborate across teams to address environmental challenges and ensure compliance with r...

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...

Champion innovative drug development as a senior leader in nonclinical drug safety, guiding Immunology programs with scientific excellence and strategic oversight, while fostering mentorship, collabor...

Strategize nonclinical drug safety initiatives in Immunology, advancing development and regulatory strategies through leadership, collaboration, and innovation. Deliver key assessments while fostering...

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...

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...

Elevate the Promotional Review Committee's effectiveness by leading the compliant review process of promotional materials. Drive cross-functional collaboration, enhance operational workflows, and ensu...

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...

Drive the development of innovative enzyme formulations for DNA template manufacturing, ensuring stability and performance. Collaborate closely with cross-functional teams to translate scientific need...

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...