Regulatory Affairs Specialist Jobs in Cambridge, MA

Execute territory business plans to drive commercial performance, engage healthcare providers, and support product launches. Collaborate with cross-functional teams to optimize patient access and ensu...

Unlock potential by architecting methodologies to manage engineering changes, ensuring timely processing and collaboration between clients and internal teams for highly configurable products in a dyna...

Help us transform product development by managing engineering changes efficiently. Collaborate with clients and internal teams to ensure timely implementation of modifications, enhancing our highly co...

Manage compliance activities ensuring FDA regulatory adherence, overseeing audits, document control, and quality assurance protocols to maintain continuous inspection readiness and effective correctiv...

Lead the execution of clinical trials by monitoring site activities, ensuring compliance with regulations, and collaborating with teams to achieve study objectives. Play a key role in training site st...

Elevate clinical research by monitoring trials, ensuring compliance with protocols and regulations. Collaborate with investigators to achieve study goals in dermatology and rheumatology, while working...

Unlock potential by overseeing clinical trials, ensuring compliance with protocols and regulations. Collaborate with investigators and coordinators to protect participant rights and verify data integr...

Lead the charge in executing global regulatory CMC strategies for investigational and marketed products, ensuring compliance and guiding cross-functional teams through complex regulatory landscapes...

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...

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

Advance your career by leading medical writing projects in a regulatory environment. Collaborate with cross-functional teams to produce high-quality documents, ensuring compliance with industry standa...

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...

Empower quality assurance excellence by leading GMP oversight for contract manufacturing and validation projects, ensuring compliance and collaboration across technical operations to support drug deve...

Unlock your potential by engaging with clinical and technical teams to enhance radiology workflows. Drive customer interest through expert product demonstrations and support sales initiatives, ensurin...

Advance your career by leading innovation initiatives in Global Regulatory Affairs. Drive strategic improvements, establish governance frameworks, and foster a culture of continuous enhancement across...

Lead contract management initiatives by drafting, negotiating, and overseeing agreements while collaborating with cross-functional teams to enhance efficiency and support strategic legal operations in...

Empower compliance excellence by leading the NSCLC field compliance program. Collaborate with cross-functional teams to identify risks, develop scalable solutions, and ensure adherence to regulations...

Join a team that's dedicated to ensuring the quality and safety of clinical trials. As a Senior Clinical Research Associate, you'll manage site relationships, oversee monitoring activities, and contri...

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...

Shape the future of clinical research by managing site operations, ensuring patient safety, and maintaining data integrity. Collaborate with study teams to oversee monitoring activities and drive succ...

Empower your career by managing clinical research sites, ensuring patient safety, and maintaining data integrity. Collaborate with teams to oversee study implementation and monitoring, while enhancing...

Optimize document control processes by leading a QA team across multiple facilities, ensuring compliance with GMP regulations while driving strategic improvements and fostering a collaborative culture...

Elevate project outcomes by leading cross-functional teams to deliver clinical research projects on time and within budget, ensuring compliance with regulatory standards and client expectations while...

Drive quality assurance validation efforts in a dynamic biotech environment, collaborating with cross-functional teams to ensure compliance and excellence in mRNA technology. Support validation lifecy...