Regulatory Affairs Specialist Jobs in Burlington, MA

Join a dedicated team driving global regulatory strategy for early-stage oncology products. You'll execute and manage high-quality submissions and collaborate across functions to ensure compliance and...

Optimize regulatory strategies for pharmaceutical advertising and promotion, providing leadership in decision-making and collaboration across functions. Ensure compliance with FDA regulations and ment...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...

Unlock potential by leading regulatory strategy for clinical gene therapy programs. This execution-focused role drives submissions and health authority interactions while collaborating across cross-fu...

Lead the charge in ensuring compliance and operational excellence in GMP cell therapy. Utilize robust quality systems to drive investigations, CAPAs, and change controls while fostering cross-function...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the global GMP/GDP audit organization, enhancing predictive compliance intelligence while mitigating risks through advanced analytics and effective audit strategies...

Champion efficient manufacturing operations by managing technical documentation, scheduling, and training. Drive continuous improvement and cross-functional collaboration to ensure production readines...

Unlock potential by providing legal guidance for BaaS and payments initiatives, collaborating across teams to translate banking regulations into practical solutions, and ensuring compliance while fost...

Transform the future of patient safety by establishing robust procedures and policies that align with global Pharmacovigilance regulations. Collaborate cross-functionally to ensure compliance and effi...

Optimize analytical project delivery as the key QC liaison, ensuring effective communication between clients and internal teams. Drive project planning, assessments, and coordination in a fast-paced e...

Accelerate progress by leading global regulatory strategies for diverse clients, ensuring compliance and fostering relationships with key regulatory bodies to enhance project success across therapeuti...

Empower global regulatory strategies and drive business growth while leading multidisciplinary collaborations in a fast-paced environment. Leverage your expertise to guide clients through complex regu...

Lead commercial management in CAPEX projects, ensuring contract compliance, risk mitigation, and value optimization to support growth. Collaborate across teams to manage contracts and claims effective...

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...

Lead the high-quality monitoring of clinical trials, ensuring compliance with regulatory standards while managing site operations, training staff, and protecting participant safety in a fast-paced, dy...

Lead the charge in quality assurance by coordinating corrective actions and driving process improvements across departments to mitigate risks and enhance manufacturing operations...

Champion the creation of high-quality regulatory documents, managing writing tasks and leading reviews. Collaborate across teams to ensure clarity and compliance, mentoring junior writers while delive...

Unlock your potential by engaging key Gastroenterology stakeholders, driving product utilization, and exceeding sales goals through strategic collaboration and compliance in a dynamic healthcare envir...

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...

Join a dynamic team as a Regulatory CMC Senior Manager, driving global regulatory strategies, lifecycle management, and cross-functional collaboration to advance innovative products in a fast-paced en...

Lead the charge in optimizing manufacturing operations and supply chain efficiency. Collaborate cross-functionally to ensure timely production scheduling and vendor management, while maintaining budge...

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...

Join a team that's redefining operational excellence by leading quality assurance, compliance, and governance initiatives across segments, ensuring standards are met while fostering collaboration and...

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...