Director, Regulatory Affairs Jobs in Lexington, MA

Pioneer innovative regulatory strategies to enhance clinical trials and maintain compliance in General Medicine. Lead U.S. regulatory initiatives, ensuring adherence to local laws while collaborating...

Drive innovative access strategies for oncology diagnostics, shaping payer engagements to enhance patient adoption and reimbursement efficacy globally. Collaborate with cross-functional teams to integ...

Join a dynamic team to drive manufacturing and operational plans ensuring compliance, quality, and efficiency for commercial and clinical products. Collaborate with leadership to improve processes and...

Join our dynamic team to lead international regulatory submissions for innovative digital health technologies, ensuring compliance across global markets and collaborating cross-functionally for succes...

Accelerate CMC project execution through strategic planning and cross-functional collaboration, overseeing timelines, budgets, and deliverables from early development to commercial readiness...

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...

Elevate clinical supply chain operations for global trials, overseeing activities like packaging, distribution, and logistics while ensuring compliance and fostering key relationships to support produ...

Join a team that leads the statistical strategy for clinical trials and evidence generation. Drive project outcomes, mentor talent, and ensure regulatory compliance while innovating biostatistical met...

Deliver strategic leadership in GCP quality assurance, ensuring compliance across clinical development programs. Collaborate with cross-functional teams to maintain high standards and readiness for in...

Accelerate your career by leading digital transformation in Global Development IT. Collaborate with diverse teams to enhance operational efficiency through innovative solutions and frameworks that dri...

Champion excellence in biologics quality oversight, leading strategic initiatives and cross-functional collaboration to ensure compliance and innovation across global product development, while enhanc...

Transform the quality landscape in biologics by leading a global team dedicated to compliance, innovation, and product excellence. Unleash your leadership to implement strategic quality initiatives wh...

Drive compliance excellence by overseeing accreditation and regulatory standards, enhancing patient safety, and fostering a culture of quality improvement across healthcare teams. Collaborate on risk...

Lead compliance for Medicare Advantage and ACO programs, overseeing regulatory adherence and operational excellence. Collaborate with internal teams and external partners to ensure effective complianc...

Drive nonclinical development strategies, ensuring high-quality toxicology and DMPK oversight from IND-enabling to late clinical stages. Collaborate cross-functionally and provide scientific leadershi...

Join a team that's dedicated to strategic GCP Quality oversight, driving compliance across clinical programs while collaborating with industry leaders. Enjoy a dynamic, innovative environment with a s...

Shape R&D data governance by establishing robust frameworks and ensuring compliance. Collaborate with cross-functional teams to drive effective data management, enhance data quality, and enable scient...

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...

Elevate your career by leading Governance, Risk, and Compliance within a dynamic cybersecurity environment. Oversee risk management, establish strong frameworks, and collaborate across teams to drive...

Shape the future of U.S. trade and distribution; lead strategy, operationalize models, and build partnerships to ensure smooth commercial launches and product availability across diverse channels in a...

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...

Shape the future of clinical trials by overseeing financial management and operational excellence, ensuring alignment with regulatory standards and delivering high-quality, efficient trial activities...

Unlock impactful health outcomes by leading US HEOR and real-world evidence strategies, collaborating with stakeholders, and ensuring scientific rigor in evidence generation for optimal product value...

Advance global medical affairs by leading strategic initiatives across tumor types. Drive scientific excellence, ensuring targeted and compliant communication. Collaborate with multidisciplinary teams...

Empower clinical research strategies in neurology, leading complex studies and multi-disciplinary teams to deliver innovative therapies, while ensuring compliance with regulatory standards and excelle...