Regulatory Affairs Manager Jobs in Burlington, MA

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...

Join a team that's committed to advancing clinical trials by overseeing regulatory operations and ensuring compliance across multiple studies within a dynamic environment, while collaborating with var...

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...

Elevate site Quality Operations by leading compliance initiatives, managing regulatory activities, and ensuring product quality and inspection readiness while inspiring a team focused on excellence an...

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 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...

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...

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...

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

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...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

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...

Lead regulatory support for Neurology and Oncology agents, driving strategies and submissions for global approvals. Collaborate across teams to enhance development timelines and ensure compliance with...

Lead the charge in regulatory CMC strategies for small molecules, ensuring compliance from development to market. Collaborate with cross-functional teams to navigate regulatory complexities and drive...

Drive project success by managing contracts and claims for CAPEX schemes, ensuring compliance, optimizing costs, and mitigating risks. Collaborate with engineering and procurement teams to enhance sup...

Join a team that's enhancing risk management and governance through innovative audit leadership. Drive impactful audit engagements, collaborate with senior leaders, and foster continuous improvement i...

Elevate your career by leading compliance and quality in clinical trials. Collaborate with teams to ensure protocol adherence, site training, and resolve issues while maintaining high standards of mon...

Tackle clinical monitoring challenges while leading site initiatives for quality compliance and protocol adherence. Collaborate with cross-functional teams to ensure successful clinical trial executio...

Optimize your clinical research career by playing a vital role in overseeing and conducting site monitoring for clinical trials, ensuring compliance, quality, and effective team collaboration througho...