Senior Regulatory Affairs Specialist Jobs in Cambridge, MA

Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...

Elevate legal strategies by leading commercial contracting initiatives across U.S. and Canada for MedSurg operations. Collaborate with business leaders to navigate complex agreements while ensuring co...

Oversee promotional material reviews and ensure regulatory compliance in the pharmaceutical sector. Collaborate with cross-functional teams to align business objectives with FDA regulations, driving i...

Deliver advanced technical support for GMP vaccine manufacturing, acting as a manufacturing SME. Collaborate cross-functionally to ensure process efficiency, quality, and compliance, driving continuou...

Lead and innovate in managing complex CMC projects, ensuring regulatory compliance while driving strategic direction. Collaborate with cross-functional teams and represent the organization to key stak...

Support the evolution of RNA and LNP manufacturing processes, contributing hands-on to the production of preclinical drug substances. Collaborate cross-functionally while ensuring high-quality outputs...

Elevate product quality through rigorous engineering practices, supporting end-to-end design, manufacturing, and supplier quality management. Collaborate with cross-functional teams to enhance complia...

Drive quality engineering initiatives to enhance product reliability and compliance. Collaborate with cross-functional teams, ensuring adherence to industry standards while implementing robust quality...

Deliver high-quality clinical monitoring in a fast-paced environment. Lead site management, ensure adherence to protocols, and guarantee participant safety. Collaborate effectively while adapting to c...

Engage with cross-functional teams to drive enhancements and ensure compliance of medical devices throughout their lifecycle. Support technical investigations, product improvements, and sustain engine...

Drive innovative product development from concept to production as you leverage your technical expertise and customer-centric vision. Collaborate with cross-functional teams to enhance product offerin...

Join a team that's committed to elevating product safety through compliance testing, ensuring designs adhere to rigorous international standards and regulations while collaborating across functions to...

Transform analytical capabilities in a biotech firm by executing complex QC assays and ensuring reliable product consistency. Collaborate cross-functionally while leading training initiatives and refi...

Transform the quality landscape by serving as the technical authority for sterility assurance and validation. Support sterilization processes and ensure compliance while driving quality engineering in...

Drive operational excellence in QC Analytical Lab by leading testing activities, ensuring compliance with regulations, mentoring staff, and managing resources to support product releases and process v...

Drive your career forward as you manage critical Pharmacovigilance activities, ensuring safety compliance and signal management for clinical trials and products. Collaborate with teams to analyze data...

Join a team that's advancing microbiology diagnostics by driving scientific initiatives, fostering collaborations, and supporting clinical studies, ultimately enhancing product visibility and scientif...

Join as a Clinical Research Associate to oversee critical monitoring tasks across diverse clinical studies. Ensure high-quality standards while facilitating communication between project teams and sit...

Shape the future of quality assurance by driving enhancements in laboratory processes, ensuring compliance with specifications, and collaborating across departments to elevate product standards and re...

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...

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...

Unlock your potential as a senior engineer, collaborating on structural design projects for nuclear facilities. Guide junior team members and harness your expertise in advanced materials and structura...

Lead innovative structural engineering projects for nuclear facilities, collaborating with multidisciplinary teams to advance designs and guide junior engineers. Your expertise will drive quality and...

Join a team that's shaping the future of Patient Safety with digital solutions. As a key player in Clinical Safety and Pharmacovigilance systems, you'll oversee system operations, drive innovative cap...

Join our dynamic Regulatory Affairs team to drive global regulatory strategy, manage submission planning, and engage health authorities, contributing to innovative oncology programs in a fast-paced, c...