Regulatory Affairs Specialist Jobs in Burlington, MA

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

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

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...

Shape the future of regulatory submissions by ensuring high-quality QC reviews of clinical documents. Collaborate with global teams to meet project timelines while maintaining compliance with industry...

Elevate clinical outcomes by serving as the key pharmacist liaison among partners, translating real-world issues into actionable insights, driving resolution of clinical concerns, and enhancing produc...

Lead the charge in designing and delivering global real-world evidence studies that drive impactful insights, inform stakeholder decisions, and advance scientific understanding in diverse disease area...

Take ownership of quality control digital transformation initiatives, supporting AI-driven solutions and collaborating across teams to enhance laboratory operations and compliance with regulatory stan...

Join us to perform essential QC analytical chemistry testing, supporting release and stability for clinical and commercial products. Collaborate on projects while ensuring compliance with cGMP regulat...

Engage in ensuring the quality of clinical and commercial products through meticulous QC chemistry testing, data analysis, and compliance with regulatory standards in a collaborative lab environment...

Join our dynamic team as you manage quality control in analytical chemistry, executing tests, supporting compliance, and contributing to project success with precision in a collaborative lab environme...

Manage compliance oversight for global R&D, ensuring alignment with regulations and company practices. Collaborate with cross-functional teams, provide training, and monitor compliance landscapes to a...

Manage operations and administration for Medical and Clinical Affairs, ensuring efficient execution of programs and initiatives while coordinating cross-functional teams and maintaining strong stakeho...

Join us to lead operations and administration for Medical Affairs, overseeing grants, coordinating governance committees, and enhancing project progress while managing departmental finances and suppor...

Join a dynamic team as you manage clinical research sites, ensuring compliance and quality throughout all study phases. Build strong relationships, oversee monitoring activities, and contribute to tea...

Tackle quality assurance challenges by reviewing batch documentation, ensuring compliance with cGMPs, and enhancing investigative processes. Collaborate cross-functionally to uphold product integrity...

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...

Optimize global regulatory strategy for cutting-edge cell therapies, leading high-impact programs from development through licensure. Collaborate with teams, ensure competitive pathways, and drive pat...

Lead the charge in ensuring continuous regulatory compliance and inspection readiness for R&D technology solutions by executing audit readiness strategies, embedding GxP compliance, and collaborating...

Champion clinical strategies within cross-functional teams to enhance product development for innovative medical devices. Collaborate on clinical protocols, evidence generation, and regulatory submiss...

Unlock packaging compliance excellence by leading cross-functional strategies to ensure global adherence to evolving regulations. Drive sustainability initiatives while championing innovative solution...

Join a team that's committed to ensuring compliance and accountability in construction by performing detailed audits of payment applications, guiding project owners, and fostering best practices acros...

Manage regulatory strategies for AI-enabled medical imaging software, ensuring compliance across FDA and EU markets. Collaborate with cross-functional teams to facilitate submissions and lifecycle man...

Shape client success by leading complex consulting projects, integrating diverse workstreams into actionable insights, and driving high-quality deliverables while fostering team growth and managing st...

Unlock your potential as a full-stack engineer, blending technical expertise with product vision to create intuitive AI-driven solutions that enhance healthcare workflows and user experiences...