Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Champion global regulatory strategies for cardiovascular programs to achieve optimal labeling and expedite approvals. Leverage expertise in drug development while managing complex programs as a key re...

Drive regulatory compliance and strategy in the medical device sector, leading submission management and overseeing compliance activities. Champion innovative solutions while guiding cross-functional...

Join a team that's leading regulatory integrity in life sciences, guiding clients through complex application implementations. Oversee a skilled team in governance, risk, and compliance, ensuring oper...

Drive compliance and quality in technology systems across projects. Lead risk assessments and validation processes while mentoring junior staff. Ensure adherence to guidelines in a collaborative envir...

Lead the global regulatory function and drive innovative strategies that propel precision oncology development from early stages to market. Collaborate cross-functionally with teams to navigate comple...

Join a dynamic team as you manage and enhance ICSR processing while ensuring compliance and quality in pharmacovigilance. Collaborate with leadership to streamline processes and support critical safet...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Join an innovative team conducting vital research to enhance food safety. Contribute to developing analytical methods for detecting lead in food contact materials while collaborating with cross-functi...

Partner with us to develop robust regulatory compliance frameworks for consumer, research, and SaMD products. Collaborate with cross-functional teams to embed compliance within the product lifecycle w...

Reimagine regulatory compliance by collaborating with engineering and product teams to integrate frameworks that ensure adherence to US and global standards across SaMD and AI/ML products. Your expert...

Join a team that's driving regulatory strategy for a leading product across multiple global markets. Oversee submissions and compliance, ensuring alignment with regulations while collaborating on prod...

Lead the charge in shaping and executing the Regulatory Information Management strategy, ensuring data governance and compliance while fostering team development and cross-functional collaboration to...

Drive regulatory data strategy and governance, enhancing tradition with innovation. Collaborate cross-functionally to elevate data quality and execution while ensuring compliance and alignment with gl...

Join a team that's redefining global regulatory strategies. Lead critical CMC submissions and leverage your expertise to navigate the complex landscape of Pharma/Biotech, while mentoring talent and dr...

Architect strategic CMC regulatory frameworks for biologics development, ensuring compliance from IND through BLA filing while leading cross-functional teams and managing external partnerships within...

Empower our team as a Senior QA Specialist overseeing GMP operations, ensuring compliance with FDA and international regulations while collaborating with partners to advance our innovative gene therap...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Unlock potential by leading regulatory submissions strategy and excellence across global clinical trials, ensuring compliance and timely approvals while managing risks and aligning with project teams...

Support impactful DoD programs by providing expert administrative assistance. Ensure compliance and uphold organizational priorities while enhancing workflow efficiency, fostering collaboration, and a...

Support regulatory strategic input for U.S. promotional materials. Collaborate with cross-functional teams to ensure compliance with FDA regulations while driving business objectives in the healthcare...

Join a team that's driving innovation in drug development by leading cross-functional efforts for marketing authorization submissions. Collaborate effectively, manage project timelines, and ensure reg...

Join a dedicated global team to enhance supplier quality in medical devices. Drive compliance, manage quality issues, and lead projects to ensure patient safety and product excellence across diverse s...

Drive compliance and validation in GxP-regulated environments while ensuring the integrity of critical laboratory systems. Leverage your expertise in Hamilton Instrumentation and automation to enhance...

Lead the charge in bridging satellite technology with global regulatory frameworks, shaping policies, and advocating for spectrum assets, while executing strategic initiatives to enhance worldwide con...