Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Support the evolution of RNA and LNP manufacturing processes, contributing hands-on to the production of preclinical drug substances. Collaborate cross-functionally while ensuring high-quality outputs...

Drive clinical excellence by overseeing site management and monitoring for biotech and pharmaceutical projects, ensuring compliance and accuracy in clinical research data. Join us to impact lives thro...

Transform quality systems by driving continuous improvement and fostering a culture of excellence. Collaborate across functions to enhance compliance and efficiency, thereby elevating both employee an...

Transform analytical capabilities in a biotech firm by executing complex QC assays and ensuring reliable product consistency. Collaborate cross-functionally while leading training initiatives and refi...

Transform the quality landscape by serving as the technical authority for sterility assurance and validation. Support sterilization processes and ensure compliance while driving quality engineering in...

Drive operational excellence in QC Analytical Lab by leading testing activities, ensuring compliance with regulations, mentoring staff, and managing resources to support product releases and process v...

Drive validation efforts supporting facilities, utilities, and equipment processes, collaborating with cross-functional teams to ensure compliance and success of quality assurance projects while leadi...

Join a team that's dedicated to ensuring effective complaint handling and regulatory submissions. Lead investigations, partner with diverse teams, and drive quality improvements to enhance compliance...

Innovate and lead regulatory strategy for transformative gene therapies, shaping FDA and EU interactions. Collaborate cross-functionally to ensure compliance and accelerate patient access through exce...

Pioneer global trade compliance by enhancing processes, ensuring adherence to regulations, and collaborating across teams worldwide to improve supply chain efficiency and mitigate risk while supportin...

Join a team that drives clinical safety and compliance by leading Pharmacovigilance initiatives. Oversee safety signal processes, author critical safety reports, and mentor staff to ensure the integri...

Drive your career forward as you manage critical Pharmacovigilance activities, ensuring safety compliance and signal management for clinical trials and products. Collaborate with teams to analyze data...

Help us drive excellence in clinical research by monitoring studies across various therapeutic areas, enhancing collaboration with project teams and trial sites, and ensuring adherence to the highest...

Lead the charge in client partnerships while driving strategic growth and team development. Utilize your expertise to deliver impactful insights and solutions in a fast-paced, evolving environment, en...

Analyze and enhance audit programs to ensure compliance with regulatory standards, driving operational excellence across Trade Compliance. Collaborate with key stakeholders to implement corrective act...

Lead a structural engineering team in developing designs for nuclear facilities. Collaborate across disciplines, mentor junior engineers, and utilize advanced tools for structural analysis, ensuring q...

Join a team that's shaping the future of Patient Safety with digital solutions. As a key player in Clinical Safety and Pharmacovigilance systems, you'll oversee system operations, drive innovative cap...

Discover a senior role focused on maintenance and optimization of cutting-edge pharmaceutical equipment. Serve as a technical lead ensuring reliability and compliance while driving continuous improvem...

Join our dynamic Regulatory Affairs team to drive global regulatory strategy, manage submission planning, and engage health authorities, contributing to innovative oncology programs in a fast-paced, c...

Transform your career as you navigate environmental qualification projects for nuclear power plants, collaborating with engineering teams and ensuring the integrity of critical equipment across variou...

Shape regulatory strategy and readiness as you monitor key developments, analyze impacts, and support examinations for an efficient compliance process. Translate complex regulations into actionable in...

Transform quality technology strategy by aligning teams, enhancing processes, and driving innovation in regulated environments. Lead the charge to optimize quality management systems while fostering a...

Accelerate progress at the forefront of automation for Drug Product systems. Drive efficiency and innovation in filling, packaging, and inspection through technical leadership, design governance, and...

Innovate and enhance HSE programs by assessing risks and ensuring safety compliance in facility maintenance; partner with teams to foster a culture of safety and implement preventive measures in a dyn...

Empower quality initiatives by leading projects across teams. Ensure compliance with regulations and enhance the global quality system while addressing challenges effectively, bridging design with man...