Regulatory Affairs Manager Jobs in Cambridge, MA

Champion recall operations by managing teams, executing FDA-compliant strategies, and driving cross-functional alignment to ensure timely product corrections and removals while maintaining regulatory...

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...

Drive compliance in North American labelling processes and promotional materials. Collaborate with cross-functional teams to ensure regulatory adherence while managing product labelling development an...

Join a team that's enhancing risk management and governance through innovative audit leadership. Drive impactful audit engagements, collaborate with senior leaders, and foster continuous improvement i...

Take ownership of regulatory strategies and submissions for cutting-edge companion diagnostics. Lead a team while interfacing with cross-functional groups and regulatory authorities to navigate the ap...

Lead the development and execution of US regulatory strategies, ensuring compliance and expedited pathways for innovative therapies. Collaborate with global teams and regulatory bodies to drive produc...

Drive product quality and customer confidence by leading a team in quality investigations and continuous improvement initiatives, while fostering collaboration and accountability across functions to a...

Transform strategic GPO agreements into operations, ensuring compliance and optimal product flow while managing performance metrics and safeguarding revenue integrity across the U.S. commercial channe...

Join a dynamic team to lead strategic regulatory CMC initiatives, enhancing biopharmaceutical product development. Drive impactful CMC efforts for biologics, ensuring compliance and facilitating succe...

Lead the management of pharmacovigilance case processes, ensuring compliance and quality. Collaborate with cross-functional teams and vendors to optimize safety measures for investigational and approv...

Transform the life sciences landscape by driving eLearning growth. Own the sales process, generate leads, and cultivate customer relationships, utilizing your expertise to deliver innovative solutions...

Lead clinical data management for pivotal trials, ensuring data quality, compliance, and collaboration across teams. Drive vendor management, develop data plans, and maintain regulatory standards to s...

Lead global regulatory strategy initiatives, ensuring compliance and mitigating risks while managing the product lifecycle from development to post-approval. Drive and influence cross-functional teams...

Drive trade compliance excellence across the Americas, partnering with cross-functional teams to ensure adherence to regulations while supporting strategic growth and operational efficiency...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Drive regulatory compliance initiatives for medical devices, ensuring successful submissions and approvals in domestic and international markets. Collaborate across teams to support product developmen...

Elevate our global labeling strategy by leading end-to-end processes, driving compliance, and optimizing product positioning through precise, defensible labeling language while collaborating across te...

Transform the landscape of statistical programming by leading project teams and ensuring high-quality deliverables, guiding mentorship, and fostering collaborative development in a dynamic regulatory...

Lead the charge in developing and executing global regulatory CMC strategies for small molecule products, ensuring compliance, and enhancing organizational excellence through digital innovation and ta...

Transform critical Pharma R&D data stewardship, leading a team to ensure quality, compliance, and usability. Collaborate cross-functionally to operationalize standards, resolve data issues, and turn d...

Join a team that's driving regulatory excellence across global therapeutic strategies. Lead diverse projects, support development programs, and ensure compliance with industry standards while mentorin...

Join a dynamic team to manage product initiatives through the full life cycle, from ideation to launch, ensuring alignment with market needs and quality standards while collaborating across teams to d...

Champion operational excellence and strategic partnerships in the clinical research space. Drive financial performance and enhance client satisfaction while leading high-performing teams to achieve su...

Transform the manufacturing landscape by leading complex projects, driving cross-functional collaboration, and ensuring quality through innovative execution strategies in our external manufacturing pr...

Engage with us to lead global CMC regulatory strategies for biologics, ensuring high-quality submissions and fostering collaborative interactions with Health Authorities while implementing AI-enhanced...