Senior Regulatory Affairs Specialist Jobs in Billerica, MA

Drive regulatory strategy for innovative mRNA products in oncology and rare diseases, navigating complex landscapes to ensure successful product development and approvals. Collaborate cross-functional...

Join the CMC Development Rotation Program to explore mRNA therapeutic manufacturing. Collaborate with experts, engage in cutting-edge project rotations, and develop critical skills in drug product syn...

Join a dynamic team to oversee CAPA activities, enhance quality compliance, and drive continuous improvements in a regulated environment. Collaborate across functions to ensure timely and effective re...

Drive quality assurance in GMP operations, ensuring compliance and product integrity while collaborating with internal and external stakeholders. Contribute to clinical manufacturing excellence throug...

Drive your career forward by leading a multi-disciplinary team in sustaining engineering for medical devices. Oversee compliance, design improvements, and operational excellence while fostering a cult...

Elevate product quality by managing supplier evaluations and risk assessments. Implement effective quality systems and audit compliance to ensure manufacturers meet stringent standards for excellence...

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...

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...

Advance your career by leading deviation investigations in a cGMP setting. Collaborate across teams, mentor junior investigators, and drive the quality of investigations while ensuring compliance and...

Drive excellence by leading deviation investigations in a cGMP environment, mentoring junior investigators, and implementing effective CAPAs to enhance investigational quality and compliance...

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...

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...

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...

Join our team to enhance administrative operations within a DoD setting. You'll manage executive calendars, coordinate tasks and meetings, and support senior leadership in a dynamic, mission-focused e...

Empower your future by designing and maintaining critical IT infrastructure, ensuring optimal network performance and reliability. Collaborate with teams to meet business objectives in this dynamic sy...