Regulatory Affairs Specialist Jobs in Westborough, MA

Contribute to regulatory CMC strategies for drug development and commercialization. Lead global submissions, ensure compliance with health authority standards, and engage cross-functional teams for ri...

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...

Take ownership of project controls on transit and transportation initiatives, ensuring effective CPM scheduling, cost management, and earned value reporting through all project phases, from planning t...

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...

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...

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...

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...

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...

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...

Join a team that's advancing pharmaceutical technology transfer and quality control through analytical excellence, method validation, and leadership in a dynamic, compliance-focused environment. Drive...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

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...

Join a team that's shaping healthcare through innovative legal counsel. You'll oversee commercial contracting, guide compliance, and streamline legal operations for critical partnerships in health sys...

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...

Execute seamless operations in Medical and Clinical Affairs by managing programs, financials, and stakeholder engagement, while ensuring adherence to best practices and fostering collaboration across...

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

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...

Manage clinical studies to ensure compliance with regulations and human subject protection. Coordinate site monitoring and maintain quality standards while communicating effectively with site teams to...

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...