Director, Regulatory Affairs Jobs in Lexington, MA

Join our dynamic Regulatory Affairs team to lead global strategies in drug development, ensuring impactful outcomes for innovative therapies in the Cardiovascular, Renal, and Metabolism sectors. Drive...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Lead strategic regulatory consulting efforts for companion diagnostics, integrating insights across IVD development, clinical trials, and commercialization. Collaborate with stakeholders to ensure com...

Champion regulatory execution across gene editing programs, managing submissions, health authority interactions, and cross-functional collaboration to advance IND/CTA readiness and support impactful b...

Architect and lead global privacy and data protection initiatives, ensuring compliance with U.S. and international laws, while collaborating with cross-functional teams to promote best practices in da...

Lead the charge in optimizing manufacturing and quality operations, ensuring safety and efficiency while driving growth and compliance across dynamic diagnostic production environments. Shape strategi...

Pioneer technology strategies in Regulatory Sciences. Drive innovation and efficiency in regulatory operations with scalable tech solutions, ensuring compliance and data integrity across the product l...

Drive comprehensive global pharmacovigilance efforts, ensuring safety compliance, signal detection, and collaboration across multiple departments to support innovative therapy development and regulato...

Lead and manage a global Pharmacovigilance audit program, ensuring compliance with regulations and industry best practices. Collaborate with cross-functional teams to enhance processes and drive conti...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

Oversee the execution and monitoring of clinical trials, ensuring compliance and quality standards while leading a team of field CRAs in a collaborative environment to address study-related issues and...

Join a team that's redefining internal audit excellence by designing and executing a strategic risk-based audit plan, enhancing governance, and driving continuous improvement across global operations...

Champion transformative regulatory strategies, shaping industry standards by driving the adoption of innovative software solutions to enhance efficiency in regulatory submissions for biotech companies...

Drive the development of compliance initiatives, focusing on transparency reporting and risk assessment. Collaborate cross-functionally to enhance compliance programs and ensure adherence to regulatio...

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...

Shape global trade strategies while ensuring compliance and operational excellence. Drive transformation and influence executive leadership to support innovation-driven growth across life sciences. Le...

Shape the future of legal strategy and compliance by leading a high-performing legal team that partners with senior leadership to navigate complex business challenges and mitigate risks while ensuring...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Shape the future of healthcare compliance by managing governance for Medicare and Medicaid programs. Collaborate with cross-functional teams to enhance compliance, optimize quality of care, and improv...

Elevate your career by driving global GMP inspection readiness and management programs. Collaborate cross-functionally to ensure compliance and continuous improvement within internal and external manu...

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...

Drive regulatory strategies and compliance for high-risk medical devices, ensuring successful market approval and navigating complex global regulations while collaborating with cross-functional teams...

Partner with us to lead regulatory affairs initiatives, ensuring compliance with FDA advertising guidelines while fostering relationships across departments and driving promotional review processes fo...

Tackle regulatory challenges by ensuring compliance in promotional communications and submissions. Collaborate with cross-functional teams, lead PRC activities, and liaise with the FDA to support stra...