Director, Regulatory Affairs Jobs in Lexington, MA

Manage preventive maintenance and compliance for operational readiness in facilities, ensuring alignment with cGMP and ISO 13485 standards. Lead a dedicated team to maintain facility integrity while i...

Join us as a Senior Manager in Pharmacoepidemiology to lead impactful projects, generating real-world evidence while guiding cross-functional teams in a dynamic regulatory environment, enhancing patie...

Shape patient-centered strategies by integrating lived experience data, bridging regulatory and medical affairs to drive therapeutic advancements. Lead cross-functional teams to ensure the patient voi...

Champion strategic litigation and policy initiatives that shape drug pricing and access to optimize patient care within a dynamic regulatory landscape. Collaborate with cross-functional teams to advan...

Grow your career with a dynamic legal team by advising on commercial agreements, supporting sales teams, and navigating complex transactions in a fast-paced, technology-driven environment. Collaborate...

Lead and optimize global clinical data management operations, ensuring the delivery of high-quality, compliant datasets throughout clinical trials. Drive innovation and data governance, mentoring team...

Elevate global clinical supply strategies across Phase I-III trials. Collaborate with cross-functional teams to ensure uninterrupted supply, manage vendor relations, and drive continuous process impro...

Lead the charge in developing and scaling innovative drug substance processes to drive product commercialization. Oversee a team of 30+ scientists and engineers, ensuring efficiency, safety, and excel...

Join a team that redefines evidence generation in rare diseases by leading global real-world evidence initiatives, driving strategic partnerships and overseeing high-impact research to support innovat...

Join a team that's committed to enhancing global compliance operations and investigations. Lead a high-performing team, ensuring adherence to ethical practices and regulatory standards while managing...

Partner with commercial leadership to design and execute HR strategies that drive talent development, organizational effectiveness, and sustainable growth across a diverse commercial landscape...

Lead the charge in elevating event strategy and operations, ensuring impactful execution of U.S. meetings and congresses while fostering collaboration across teams. Drive operational excellence and co...

Lead the charge in ensuring compliance with medical device regulations and maintaining quality standards. Manage a dynamic team while driving improvements in complaint handling and submissions, promot...

Drive excellence in clinical data management by overseeing activities supporting all phases of drug development. Collaborate cross-functionally to ensure compliance, optimize data collection, and enha...

Transform clinical data management by overseeing all aspects of data activities and partnering with cross-functional teams to ensure compliance and integrity of data in clinical studies, driving innov...

Innovate your career by leading technology strategy for a portfolio of products. Collaborate with cross-functional teams to deliver scalable solutions that enhance commercial operations and drive busi...

Champion the management of complex contracts and claims for impactful capital projects. Utilize your extensive experience in strategic negotiation, risk assessment, and commercial management to drive...

Lead high-impact medical strategies for early-stage development in a dynamic team. Engage with cross-functional partners and healthcare professionals to shape communications around our innovative ther...

Explore impactful opportunities to drive health system adoption of innovative diagnostics, building strategic relationships while leading expansion efforts, managing complex contracts, and orchestrati...

Shape the future of regulatory compliance by coordinating international submissions and registrations for medical devices. Collaborate with cross-functional teams to ensure timely approvals and mainta...

Support clinical trials through effective medical monitoring and oversight. Ensure adherence to protocols and GCP while engaging with investigators and cross-functional teams to maintain data integrit...

Join a team that's shaping the future of clinical trials by driving operational strategies and ensuring successful study delivery, impacting lives through innovative neurological research in a flexibl...

Deliver exceptional leadership to a vast Field Service organization, driving operational excellence, customer retention, and strategic growth. Collaborate cross-functionally to enhance service deliver...

Manage integrated marketing client relationships while leading strategy, analytics, and omnichannel execution. Serve as a key client partner, ensuring delivery excellence, profitability, and alignment...

Innovate real-world evidence strategies to support healthcare providers and improve population health. Collaborate cross-functionally to design and disseminate impactful HEOR studies, ensuring scienti...