Director, Regulatory Affairs Jobs in Waltham, MA

Lead transformative QSP strategies, integrating biology and mathematics to enhance drug development and clinical efficacy, while collaborating across teams for optimal therapeutic insights and decisio...

Unlock potential by leveraging your quantitative pharmacology expertise to shape drug development through innovative pharmacometric analyses and strategic collaboration across cross-functional teams...

Drive the global patient advocacy strategy, enhancing engagement with rare disease communities to improve health outcomes and foster partnerships that support patient needs across multiple disease are...

Lead a team in executing, overseeing, and improving corporate audits while ensuring compliance and governance align with industry standards. Engage with management to add value through strategic insig...

Join a team that's shaping the future of drug safety! Provide operational leadership across pharmacovigilance functions, oversee compliance and vendor relationships, and ensure high-quality safety rep...

Engineer the future of therapeutic protein manufacturing by leading Upstream and Downstream operations, ensuring compliance with cGMPs, and driving team performance through innovative solutions and co...

Lead daily manufacturing operations, fostering an engaged team and driving safety, quality, and productivity while implementing continuous improvement strategies for operational excellence and future...

Unlock potential by leading the deployment of Automated QC systems across manufacturing sites. Collaborate with cross-functional teams to ensure cGMP compliance, manage AQC technology life cycles, and...

Transform strategic client engagements by leading Medical Affairs initiatives. Drive capability building, develop actionable solutions, and enhance operational effectiveness while delivering high-qual...

Innovate your career by leading advanced clinical pharmacology strategies in oncology. Collaborate with cross-functional teams to enhance drug development and clinical trial design, ensuring optimal e...

Help us enhance quality assurance in external manufacturing operations through thorough documentation review, proactive communication, and participation in audits to ensure compliance and product reli...

Unlock potential by leading the development of Regulatory Affairs processes. Collaborate with teams on EU MDR compliance, manage complex projects, and ensure adherence to global regulations while fost...

Champion innovative patient marketing strategies that drive engagement and awareness for a first-in-class therapy in Becker muscular dystrophy, collaborating across teams to enhance patient experience...

Lead the charge in cross-functional project management to drive CMC activities, ensuring alignment with program objectives, budgets, and milestones across the vaccine development lifecycle...

Join a team that's transforming client relationships through innovative business and technology solutions while leading account managers to ensure operational excellence and exceptional client satisfa...

Lead the charge in developing and executing US Medical Affairs strategies in Oncology, providing expert oversight and fostering key relationships in a dynamic environment to enhance product developmen...

Unlock potential by joining a dynamic team focused on oncology medical affairs, collaborating across disciplines to enhance product strategy and support groundbreaking research. Engage with experts to...

Advance your career by leading innovative digital marketing initiatives to enhance patient engagement and education in oncology. Collaborate with cross-functional teams to execute impactful campaigns...

Champion quality strategy and governance across the organization to enhance predictive insights, drive compliance, and facilitate cross-functional collaboration for Enterprise Quality Councils...

Shape commercial strategies and market positions for innovative product pipelines, collaborating with cross-functional teams to enhance asset value and drive market success through market research ins...

Transform product reliability through dynamic leadership and cross-functional collaboration, ensuring adherence to customer requirements and successful execution of DfR initiatives while engaging in c...

Architect integrated clinical strategies for URO technologies, leveraging global insights to guide evidence generation, regulatory alignment, and strategic partnerships within the clinical research do...

Optimize enterprise data governance and management strategies, ensuring compliance, quality, and accessibility across clinical and commercial data. Collaborate with cross-functional teams to drive dat...

Pioneer business development initiatives in the CRO market, driving growth through strategic relationships and sales excellence. Own your territory by managing complex sales cycles and delivering high...

Architect innovative medical strategies for GI products, leading a cross-functional team to enhance patient outcomes. Collaborate on evidence generation and budget management while evolving strategies...