Director, Regulatory Affairs Jobs in Waltham, MA

Build a high-performing team for global CMC strategy in biologics, ensuring compliance and successful delivery of regulatory submissions across functions. Drive alignment and influence key stakeholder...

Lead innovative global regulatory strategies to drive clinical stage program success, ensuring compliance and strategic alignment from discovery through to IND submissions in a fast-paced, collaborati...

Drive global regulatory strategy for medical imaging products, ensuring compliance across the software development lifecycle. Lead a dynamic team, engaging with cross-functional partners and regulator...

Innovate global regulatory strategies for oncology, overseeing development lifecycle from early clinical through commercialization, ensuring alignment with corporate goals and leading cross-functional...

Shape global RegCMC strategies for small molecules, ensuring timely regulatory submissions. Collaborate across teams to mitigate risks and advance clinical development in a dynamic biotech environment...

Pioneer innovative regulatory strategies and ensure compliance for new products throughout their lifecycle, collaborating closely with teams and health authorities to meet corporate goals and enhance...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Drive regulatory strategies that shape rare disease programs. Lead cross-functional teams and communication with global health authorities. Make a meaningful impact through hands-on execution and stra...

Lead the charge in advancing global CMC regulatory strategies for gene therapy products. Oversee lifecycle management, change management, and compliance to ensure successful post-approval activities w...

Join a team that's driving regulatory strategy for a leading product across multiple global markets. Oversee submissions and compliance, ensuring alignment with regulations while collaborating on prod...

Advance global regulatory strategy and submissions for rare disease medicines across major markets, partnering with stakeholders to ensure compliance and successful engagement with health authorities...

Lead the global regulatory function and drive innovative strategies that propel precision oncology development from early stages to market. Collaborate cross-functionally with teams to navigate comple...

Oversee innovative regulatory strategies to support transformative clinical programs. Collaborate with cross-functional teams to ensure the preparation of high-quality regulatory submissions while dri...

Elevate global regulatory strategies for a diverse medical device portfolio, ensuring compliance and market access across regions. Lead cross-functional teams while influencing product lifecycle and e...

Shape regulatory strategies for innovative drug development in a dynamic environment, collaborating with cross-functional teams to influence project decisions and mitigate risks while maintaining comp...

Pioneer regulatory excellence by leading FDA submissions and compliance. Manage the lifecycle of medical product filings, ensuring alignment with evolving regulations across diverse jurisdictions in a...

Lead the charge in advancing novel gene-based therapies by guiding regulatory CMC strategy. Collaborate with cross-functional teams and external partners to ensure compliance and drive successful subm...

Lead the charge in developing innovative regulatory strategies for CAR-T therapies, collaborating with cross-functional teams and partners to ensure compliance and successful submissions worldwide, im...

Join a team that's pioneering innovative regulatory strategies, leading global CMC submissions, and enhancing compliance throughout drug development to deliver transformative therapies to patients wor...

Unlock potential by driving regulatory strategies for innovative IVD medical devices. Collaborate cross-functionally to ensure compliance, lead project updates, and support global submissions in a dyn...

Shape the future of biologics by leading regulatory CMC strategies and submissions. Mentor teams, manage complex projects, and ensure compliance across domestic and international regulations, driving...

Optimize promotional compliance and strategy by leading regulatory initiatives across brands. Collaborate cross-functionally to ensure effective communication while mitigating risks within a dynamic p...

Drive regulatory compliance and strategy in the medical device sector, leading submission management and overseeing compliance activities. Champion innovative solutions while guiding cross-functional...

Unlock potential by leading regulatory strategies in CMC. Collaborate with cross-functional teams to ensure successful product submissions and lifecycle management, while mentoring staff and driving e...

Advance your career in regulatory advertising by leading compliance initiatives for promotional materials. Provide strategic guidance across teams, ensuring effective communications that satisfy FDA r...