Regulatory Affairs Manager Jobs in Waltham, MA

Join us to shape global Regulatory CMC strategies, driving late-stage development and regulatory submissions across various programs while building a robust function to meet evolving compliance needs...

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

Strategize your career as a Project Manager, overseeing clinical research studies, ensuring compliance with regulations, and driving team collaboration to meet trial milestones within set timelines. J...

Optimize regulatory CMC strategies for clinical and commercial products, leading cross-functional efforts to ensure compliance while monitoring global CMC trends and guiding teams through regulatory p...

Manage and enhance compliance programs across various regulations, ensuring operational integrity and adherence to healthcare standards while fostering a culture of ethical practice and oversight with...

Unlock potential by leading global regulatory CMC activities, developing strategies for product lifecycle management, and collaborating across teams to ensure successful agency submissions. Drive tran...

Unlock potential by leading regulatory compliance for advertising and promotional materials, guiding cross-functional teams in strategic initiatives, and ensuring adherence to industry standards and F...

Pioneer innovative regulatory strategies to enhance clinical trials and maintain compliance in General Medicine. Lead U.S. regulatory initiatives, ensuring adherence to local laws while collaborating...

Reimagine regulatory compliance by collaborating with engineering and product teams to integrate frameworks that ensure adherence to US and global standards across SaMD and AI/ML products. Your expert...

Partner with us to develop robust regulatory compliance frameworks for consumer, research, and SaMD products. Collaborate with cross-functional teams to embed compliance within the product lifecycle w...

Elevate your career by managing complex claims and coordinating key defense strategies in a fast-paced environment. Drive efficient resolution processes while collaborating with stakeholders and maint...

Lead the charge in enhancing quality assurance programs by steering a talented team. Drive AI integration and continuous improvement to ensure accuracy, reduce risks, and optimize client outcomes thro...

Oversee quality and compliance for subcontractors in pharmaceutical operations, ensuring adherence to cGMP guidelines and driving continuous improvement in quality systems across North America and glo...

Join our dynamic Regulatory Affairs team to lead global strategies in drug development, ensuring impactful outcomes for innovative therapies in the Cardiovascular, Renal, and Metabolism sectors. Drive...

Lead regulatory review and compliance for promotional materials across media, ensuring adherence to FDA regulations, managing cross-functional collaboration, and establishing governance processes to m...

Drive global Medical Affairs initiatives, ensuring scientific excellence in partnerships across departments, clinical studies, and commercial success. Shape evidence strategies and deliver impactful s...

Drive success by leveraging strong client relationships and sales acumen to expand our sample management services in pharma and academic markets, ensuring exceptional customer service and achieving sa...

Join a team that's dedicated to promoting innovative engineering solutions while providing technical expertise and building strong relationships within the engineering community across the USA and Can...

Advance global regulatory CMC strategies and lead submissions throughout the product lifecycle. Collaborate across project teams to ensure compliance and success in drug development and commercial ope...

Shape the future of clinical trial quality management by leading risk-based approaches to ensure patient safety and data integrity. Collaborate cross-functionally to implement effective risk managemen...

Lead and mentor a dynamic team, driving patient access strategies through expert virtual education of healthcare providers and optimizing reimbursement processes across a national landscape...

Unlock potential by leading regulatory submissions strategy and excellence across global clinical trials, ensuring compliance and timely approvals while managing risks and aligning with project teams...

Champion recall operations by managing teams, executing FDA-compliant strategies, and driving cross-functional alignment to ensure timely product corrections and removals while maintaining regulatory...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Drive compliance in North American labelling processes and promotional materials. Collaborate with cross-functional teams to ensure regulatory adherence while managing product labelling development an...