Director, Regulatory Affairs Jobs in Lexington, MA

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

Oversee and enhance QC operations for biologics, managing stability and method validation while ensuring compliance and robust testing across CDMOs and contract labs. Lead teams and collaborate cross...

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...

Engage in enhancing compliance and operational excellence by leading the evolution of Quality Systems into a digital-first framework. Shape a data-driven ecosystem supporting clinical to commercial op...

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

Champion business growth by overseeing client relationships and sales strategies. Engage with key accounts, analyze opportunities, and lead the sales process to drive success in the healthcare sector...

Lead cross-functional teams to drive CMC strategy for small molecule products, managing project plans and budgets from development through commercialization while ensuring regulatory compliance and te...

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...

Pioneer innovative biologics drug product development in a fast-paced environment. Oversee formulation and manufacturing processes, collaborate with cross-functional teams, and drive project success w...

Accelerate business growth by developing strategic plans and sales strategies. Identify new markets and opportunities, lead proposal processes, and engage with clients to secure profitable service con...

Lead the charge in developing strategic sales plans and identifying new business opportunities in the CRO industry, while cultivating relationships with key pharmaceutical and biotech stakeholders for...

Transform our product portfolio by leading technology strategy and innovation, driving continuous improvement in protocol digitization and biospecimen management across global development initiatives...

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...

Elevate patient healthcare by leading cross-functional teams in biologics development. Drive strategic initiatives from early development through launch while ensuring compliance with regulatory stand...

Lead the charge in Medical Affairs for Pediatric Cholestatic Rare Disease, shaping strategies and fostering cross-functional collaboration to enhance patient outcomes through strategic medical insight...

Join a team that's leading compliance strategy in a rapidly growing healthcare organization. Drive initiatives, lead cross-functional teams, and ensure adherence to regulatory standards as a trusted a...

Optimize quality systems within a dynamic pharmaceutical environment, ensuring compliance with US and international standards. Drive improvements, support cross-functional collaboration, and manage a...

Lead GMP quality assurance initiatives, ensuring compliance and excellence in manufacturing, testing, and distribution processes. Champion a culture of transparency and continuous improvement while in...

Reimagine nonclinical safety as the Head of Toxicology, leading a team to ensure scientific excellence and strategic oversight across discovery and development programs for small-molecule therapeutics...

Champion global regulatory strategies for oncology programs, leading teams to ensure compliant and timely submissions across multiple regions while mentoring junior colleagues and optimizing interacti...

Shape and lead global strategic alliances, fostering growth through executive relationships, driving revenue generation, and overseeing a dynamic portfolio of partners while implementing best practice...

Transform Quality Management Systems by leading strategic initiatives and governance. Oversee continuous improvement efforts and ensure compliance with regulatory standards while managing a dedicated...