Regulatory Affairs Specialist Jobs in Cambridge, MA

Take ownership of QA operations in radiopharmaceutical manufacturing, ensuring cGMP compliance, conducting audits, resolving quality events, and fostering a culture of continuous improvement within cr...

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...

Drive regulatory excellence for promotional activities in a dynamic, compliance-focused environment. Lead cross-functional collaboration to ensure alignment with FDA regulations and corporate objectiv...

Transform compliance practices by leading structured reviews for federal health programs. Utilize strong judgment and analytical skills to ensure adherence to requirements and maintain documentation...

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

Elevate laboratory operations by streamlining workflows, enabling collaboration among diverse scientific disciplines, and improving efficiencies to accelerate the discovery of new therapeutic candidat...

Transform strategic GPO agreements into operations, ensuring compliance and optimal product flow while managing performance metrics and safeguarding revenue integrity across the U.S. commercial channe...

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...

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 us to lead risk-based quality management in clinical trials, driving comprehensive quality assessments and ensuring inspection readiness. Collaborate with teams to uphold high standards in pharma...

Analyze and enhance audit programs to ensure compliance with regulatory standards, driving operational excellence across Trade Compliance. Collaborate with key stakeholders to implement corrective act...

Innovate product labeling strategies and ensure regulatory compliance across development and post-approval processes. Collaborate with diverse teams to align content with regulatory requirements and b...

Oversee the regulatory strategy for biologics and ATMPs, driving global compliance and alignment across functions. Lead a team in managing submissions, approvals and lifecycle activities in a fast-pac...

Lead the CMC regulatory strategy for biologics and ATMPs, overseeing resources and alignment with technical development. Foster collaboration for timely approvals and lifecycle progress in a fast-pace...

Support analytical method lifecycle management, instrument qualification, and compliance across GMP operations. Collaborate with cross-functional teams to ensure effective and compliant analytical sys...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Lead global post-market regulatory compliance strategies by managing vigilance, safety investigations, and lifecycle programs, while collaborating across teams to ensure adherence to international reg...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Transform consumer compliance by investigating regulatory disputes, shaping policy, and collaborating across teams to ensure responsible growth and adherence to laws impacting financial operations and...

Join us in driving regulatory strategies and supporting successful product commercialization in North America. Utilize your expertise to lead cross-functional initiatives and ensure compliance with ev...

Join us to support global regulatory activities throughout product lifecycles, collaborating cross-functionally for high-quality submissions and interactions with health authorities. Bring your expert...

Transform global regulatory activities through effective strategy, submission preparation, and compliance. Drive high-quality interactions with health authorities while managing multiple priorities in...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

Lead the charge in drafting and managing critical legal agreements related to quality and regulatory compliance, collaborating cross-functionally to ensure organizational standards and obligations are...

Advance your career by ensuring compliance in clinical studies, managing site interactions, and driving quality throughout the research process. Collaborate with teams to support study start-up and mo...