Director, Regulatory Affairs Jobs in Cambridge, MA

Lead the charge in advancing quality assurance for cutting-edge radiopharmaceuticals. Oversee development quality, regulatory compliance, and team leadership, ensuring alignment with GMP and enhancing...

Join a dynamic team to lead clinical studies, ensuring strategic execution and oversight in neuropsychiatric drug development. Drive collaboration across departments and contribute to regulatory frame...

Elevate analytics capabilities by leading data-driven strategies in market access and channel performance, supporting business needs with a mix of hands-on analysis and strategic insight...

Drive access to innovative therapies while collaborating with cross-functional teams to enhance patient support. This role focuses on navigating the reimbursement landscape and educating healthcare pr...

Join as a strategic leader in GCP Quality Assurance, guiding compliance and risk management for clinical trials. Your expertise ensures adherence to regulations, drives quality improvement, and suppor...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Lead and transform analytical development and quality control, overseeing strategies for product lifecycle management, ensuring compliance, and fostering innovation while managing high-performing team...

Empower enterprise-wide quality initiatives through advanced analytics leadership, driving cross-functional collaboration, regulatory compliance, and data governance while developing a high-performing...

Transform analytics capabilities and lead cross-functional programs that enhance Quality Compliance and risk management. Join a dynamic team driving data-driven strategies across the medical device li...

Drive advanced analytics initiatives for Quality Compliance and risk management. Lead complex cross-functional programs, enhancing data-driven decision-making and establishing rigorous governance stra...

Lead the development of CMC regulatory strategies, ensuring successful product submissions and agency interactions. Collaborate with cross-functional teams to influence outcomes and maintain complianc...

Engage with key stakeholders to define CMC regulatory strategies, ensuring successful product delivery and first-pass approvals. Leverage expert insights to navigate complex submissions and foster str...

Drive innovation in biotech by collaborating with a dynamic team, influencing product development processes, and enhancing therapeutic solutions that improve patient outcomes...

Serve as a key player in regional regulatory strategy execution, leading submissions and cross-functional collaboration to ensure compliance across development projects, while optimizing interactions...

Empower the execution of CMC strategies by collaborating across teams to enhance production, streamline operations, and drive commercial success for innovative therapeutics and diagnostics, ensuring a...

Lead the strategic implementation and governance of integrated data review processes across clinical programs. Drive quality and consistency in data review practices while fostering collaboration and...

Innovate solutions in antibody drug conjugate pipeline by leading CMC strategy and external manufacturing. Collaborate across teams to ensure timely delivery and compliance while driving technical exc...

Shape the strategic vision for Quality Management Systems. Lead cross-functional efforts to improve governance, compliance, and performance, while overseeing digital transformation initiatives within...

Shape GMP Quality Assurance strategies and operations to ensure clinical supply reliability and advance biologics programs through late-stage development and commercialization while collaborating with...

Elevate your career by leading impactful REMS strategies that ensure compliance and enhance patient safety. Drive cross-functional collaboration and operational excellence as you shape crucial commerc...

Drive regulatory strategy by collaborating cross-functionally to influence promotional activities, ensuring compliance while optimizing risk management for impactful business decisions across a dedica...

Lead the charge in GMP API Quality Assurance, overseeing compliance and performance management with external manufacturers. Collaborate cross-functionally to ensure inspection readiness and support a...

Empower your career with a strategic leadership role in integrated communications that enhances reputation, advances awareness of postpartum depression, and drives impactful campaigns for patients and...

Join a team that's driving strategic communications for neuropsychiatry, enhancing patient understanding of postpartum depression while fostering partnerships and innovative campaigns that make a real...

Optimize regulatory strategies for robotic surgical instruments, ensuring compliance and market access. Lead cross-functional teams, prepare vital submissions, and drive innovative product development...