Director, Regulatory Affairs Jobs in Lexington, MA

Contribute to global compliance efforts by supporting regulatory strategies, preparing submissions, and coordinating with cross-functional teams to ensure adherence to international standards in a dyn...

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...

Drive your career by developing regulatory CMC strategies for biologics, authoring submissions, and collaborating with cross-functional teams to meet corporate objectives in a dynamic environment focu...

Drive regulatory strategy for innovative mRNA products in oncology and rare diseases, navigating complex landscapes to ensure successful product development and approvals. Collaborate cross-functional...

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...

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...

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

Drive compliance and product quality in medical devices by overseeing complaint handling and post-market processes. Collaborate globally to enhance regulatory adherence and lead improvements in qualit...

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...

Take ownership of a comprehensive compliance program, ensuring regulatory readiness and effective oversight across multiple states in telehealth. Lead a team dedicated to establishing policies and fos...

Lead the charge in developing regulatory labeling strategies and compliance. Oversee the creation of core, EU, and US labeling documents, ensuring high-quality, competitive content that aligns with gl...

Grow your career with a pivotal role in delivering engaging regulatory education to the insurance sector while building client relationships and collaborating with a dedicated team to ensure complianc...

Strategize your career as a Project Manager, overseeing clinical research studies, ensuring compliance with regulations, and driving team collaboration to meet trial milestones within set timelines. J...

Join a team that's dedicated to advancing clinical studies. As a Project Manager, you'll oversee the implementation of research protocols, ensuring compliance and effective communication across teams...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Deliver comprehensive regulatory submissions and ensure compliance with FDA and global standards. Contribute expertise in the medical device field while collaborating with cross-functional teams on in...

Oversee the regulatory strategy for biologics and ATMPs, driving global compliance and alignment across functions. Lead a team in managing submissions, approvals and lifecycle activities in a fast-pac...

Lead the CMC regulatory strategy for biologics and ATMPs, overseeing resources and alignment with technical development. Foster collaboration for timely approvals and lifecycle progress in a fast-pace...

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

Lead the charge in developing global regulatory strategies to ensure product compliance and alignment with corporate goals. Provide regulatory direction across programs, collaborate with stakeholders...

Join a dynamic team to drive CMC regulatory strategies and oversee submissions in the pharmaceutical sector. Lead experts in navigating complex regulatory environments while ensuring compliance and ef...

Optimize quality operations in cGMP manufacturing for cell therapy, ensuring compliance while driving continuous improvement and fostering a culture of quality through collaboration with cross-functio...

Drive global regulatory affairs for development teams, orchestrating activities and engaging both internal and external resources to ensure successful product registration and compliance with regulato...

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...