Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

Shape the future of computer systems validation by leading compliance efforts. Assess new systems, conduct risk assessments, and provide mentorship while ensuring adherence to industry standards in a...

Drive your career forward by leading regulatory labeling and compliance strategies in a dynamic role that collaborates across teams to ensure successful product lifecycle management and adherence to i...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Drive regulatory data strategy and governance, enhancing tradition with innovation. Collaborate cross-functionally to elevate data quality and execution while ensuring compliance and alignment with gl...

Lead regulatory strategy for clinical-stage radiopharmaceuticals, ensuring compliance and effective health authority engagement. This pivotal role demands substantial experience in biotech regulations...

Lead digital quality initiatives, ensuring compliance in computer system validation across regulatory and R&D landscapes. Drive GxP adherence through collaborative support and risk assessments, enhanc...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

Shape the future of drug substance development by leading regulatory strategies for starting materials. Collaborate cross-functionally and ensure compliance with global regulations to support late-sta...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

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...

Transform regulatory affairs by leading global strategy for oncology programs. Partner cross-functionally to navigate IND submissions and health authority interactions, ensuring successful Phase 1 and...

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...

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...

Lead the charge in global post-market surveillance by overseeing deliverables, providing team leadership, and ensuring regulatory compliance for medical devices. Engage in strategy, analysis, and cros...

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...

Join our team to enhance compliance culture, driving quality and safety standards through effective investigations, documentation, and training in a dynamic manufacturing environment. Your expertise w...

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...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Transform quality operations in medical device manufacturing by ensuring compliance and enhancing processes while leading cross-functional teams for product success and regulatory adherence...

Shape the future of GMP Document Control by managing end-to-end governance, ensuring compliance with regulatory standards, and driving continuous improvement in documentation and records management pr...

Lead the charge in supplier quality enhancement initiatives, ensuring compliance with industry standards while driving continuous improvement across hardware solutions. Collaborate with cross-function...

Champion continuous improvement initiatives within the supply base, managing supplier corrective actions, conducting audits, and collaborating cross-functionally to ensure high quality standards are m...