Regulatory Affairs Specialist Jobs in Cambridge, MA

Lead model-informed drug development strategies while driving cross-functional collaboration, mentoring scientists, and enhancing regulatory compliance activities within a dynamic and innovative team...

Lead the charge in designing and executing real-world evidence studies, generating insights to inform critical business decisions and advance drug development in a collaborative environment focused on...

Drive effective contract management in a dynamic environment, overseeing all phases from negotiation to compliance. Collaborate with teams and stakeholders to ensure alignment with government standard...

Drive contract management excellence by collaborating with teams, mitigating risks, and ensuring compliance in an ever-changing government contracting landscape. Thrive in a dynamic environment while...

Lead the charge in coordinating promotional review processes, managing a talented team, and fostering cross-functional partnerships to ensure compliance and efficiency across marketing strategies in t...

Oversee quality control and assurance activities for allograft processing, ensuring compliance with regulatory standards and internal policies while enhancing the quality management system and trainin...

Accelerate progress at managing strategic pharma accounts and ensuring high-quality congress experiences. This role involves team leadership, client consultations, and comprehensive event oversight in...

Lead the development and implementation of aseptic fill-finish processes in a state-of-the-art manufacturing facility, ensuring compliance and operational excellence while driving continuous improveme...

Join a team that's dedicated to enhancing patient outcomes through strategic leadership in real-world evidence (RWE) strategies, collaborating cross-functionally to drive research initiatives in healt...

Lead IT Quality and Compliance initiatives for regulated clinical systems. Collaborate with diverse teams, ensuring compliance with FDA and EU standards while driving operational efficiency and suppor...

Lead the charge in designing and supporting critical systems, ensuring reliability and compliance while mentoring junior engineers. Your expertise will drive efficient infrastructure solutions with a...

Transform clinical evidence generation for innovative medical devices. Lead strategic initiatives across teams to enhance orthopedic solutions and improve patient outcomes while ensuring compliance an...

Partner with us to ensure quality compliance for combination products and medical devices. Engage in global teams throughout product lifecycle, uphold regulatory standards, and drive continuous improv...

Champion clinical trial execution by managing timelines, risks, and stakeholder engagement across global teams. Leverage therapeutic expertise to enhance patient value and ensure compliance, driving t...

Deliver exceptional communication strategies for biotech customers while supporting diverse high-impact projects. Collaborate with teams to advance oncology initiatives and ensure timely, high-quality...

Shape the future of cell therapy by leading drug product readiness and formulation optimization, ensuring regulatory compliance, and driving successful commercialization through innovative process dev...

Lead the management of pharmacovigilance case processes, ensuring compliance and quality. Collaborate with cross-functional teams and vendors to optimize safety measures for investigational and approv...

Elevate drug product manufacturing processes to commercial scale by leading robust, scalable designs and ensuring compliance across teams. Collaborate with R&D, QA, and MSAT while guiding projects fro...

Join a team that's dedicated to advancing clinical trials by managing projects, liaising with clients, and leading a cross-functional team to deliver successful study outcomes while ensuring high qual...

Unlock your potential in a pivotal role driving General Liability claims analysis, providing technical oversight, and enhancing collaboration between underwriting and third-party administrators to imp...

Shape strategic sales solutions across diverse pharmaceutical and MedTech clients. Leverage consultative skills to address patient access challenges, ensuring growth through collaborative relationship...

Drive the configuration and optimization of a Centralized Monitoring platform, ensuring effective risk management and compliance in clinical studies. Collaborate cross-functionally to enhance processe...

Contribute to a dynamic Compliance Investigations Program by leading investigations, analyzing findings, and collaborating with cross-functional teams. Drive ethical standards and ensure regulatory co...

Join a team that drives innovative gene-editing strategies for advanced cell therapies, enhancing operational efficiency and contributing to groundbreaking project deliverables in a fast-paced laborat...

Join a dynamic team as an Account Manager, delivering high-quality medical communications for pharmaceutical clients. You will manage projects, foster client relationships, and ensure timely execution...