Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Advance your career by ensuring compliance in clinical studies, managing site interactions, and driving quality throughout the research process. Collaborate with teams to support study start-up and mo...

Oversee the regulatory strategy for biologics and ATMPs, driving global compliance and alignment across functions. Lead a team in managing submissions, approvals and lifecycle activities in a fast-pac...

Lead the CMC regulatory strategy for biologics and ATMPs, overseeing resources and alignment with technical development. Foster collaboration for timely approvals and lifecycle progress in a fast-pace...

Shape quality engineering practices to enhance product lifecycle efficiency while mentoring team members and driving continuous improvement initiatives in a regulated environment. Take ownership of pr...

Support validation efforts for biopharmaceutical manufacturing equipment, ensuring compliance with GMP standards. Collaborate with QC and Manufacturing for process improvements and execute validation...

Join a team that's driving patient access to groundbreaking gene therapy products. Leverage your expertise in health systems and reimbursement to educate stakeholders and facilitate timely product ava...

Join a dynamic team managing a $20-25M accounts receivable portfolio, focusing on dispute resolution and collections. Collaborate with internal and external teams to enhance cash flow while delivering...

Optimize regulatory CMC strategies for clinical and commercial products, leading cross-functional efforts to ensure compliance while monitoring global CMC trends and guiding teams through regulatory p...

Join a dynamic team to design and conduct experiments in immunology, focusing on innovative approaches and solving complex biological challenges. Engage with key stakeholders while managing project mi...

Lead the implementation and oversight of Data Integrity compliance in Quality Control, managing regulatory alignment, training efforts, and data validation while enhancing processes for excellence in...

Join us in driving regulatory excellence by leading a dynamic team and managing critical global drug projects while shaping strategic initiatives and ensuring compliant operations across diverse thera...

Lead innovative global regulatory strategies to drive clinical stage program success, ensuring compliance and strategic alignment from discovery through to IND submissions in a fast-paced, collaborati...

Join a team that's dedicated to navigating regulatory landscapes and ensuring compliance across healthcare programs. Enhance your expertise by leading audits, managing project implementations, and col...

Drive excellence in testing for advanced military network systems. Collaborate with diverse teams on critical projects that shape defense capabilities, ensuring robust solutions are delivered to suppo...

Drive innovation in testing by developing strategies, leading teams, and enhancing software evaluation to ensure mission success in a dynamic environment. Collaborate across departments to optimize pr...

Lead regulatory review and compliance for promotional materials across media, ensuring adherence to FDA regulations, managing cross-functional collaboration, and establishing governance processes to m...

Analyze complex situations and drive innovative solutions to ensure the safety, compliance, and effectiveness of medical devices while collaborating with cross-functional teams throughout the lifecycl...

Join a senior leadership team to drive strategic Sterility Assurance initiatives. Oversee sterilization processes, compliance, and stakeholder relationships. Leverage your expertise in microbiology, t...

Lead cross-functional innovation efforts in medical device design assurance, ensuring compliance and quality from concept to launch. Drive initiatives that enhance product safety and reliability while...

Drive regulatory excellence by ensuring compliance for product submissions and collaborating across teams to support marketed products and development programs while fostering high performance and inn...

Drive regulatory compliance and oversee submissions for innovative medical devices. Lead a team in strategic regulatory guidance, ensuring optimal support for product launches while acting as a liaiso...

Manage key regulatory functions, guiding compliance in PBM, pharmacy, and healthcare technology. Advise on state and federal obligations, and translate regulations into practical strategies for busine...

Drive efficiency in project billing and workflow management by overseeing setup, ensuring data integrity, and facilitating vendor invoice processing in Certinia. Collaborate with finance and project t...

Unlock potential as a Senior Equipment Reliability Engineer, enhancing operational proficiency by managing risks, driving continuous improvements, and collaborating across teams to optimize reliable p...

Shape the future of Quality Control by leading laboratory operations, ensuring compliance, driving performance, and developing a high-performing team to enhance quality across pharmaceutical products...