Regulatory Affairs Specialist Jobs in Marlborough, MA

Unlock potential by supporting project compliance tracking and permitting functions. Collaborate with agencies to ensure adherence to regulations while managing documentation and communication for con...

Unlock potential as you drive US market access strategy, ensuring effective payer and provider engagement while leading reimbursement initiatives and enhancing patient access outcomes across the healt...

Manage the qualification of GMP equipment at a biopharmaceutical facility, overseeing hands-on execution of protocols, ensuring compliance, collaborating across departments, and resolving issues to en...

Lead the charge in ensuring compliance and traceability in pharmaceutical trade operations, managing serialization integrity and optimizing inventory across distribution networks while serving as the...

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...

Transform government pricing strategies by managing client relations and ensuring accurate federal drug price calculations while mentoring a team of analysts and providing expert guidance in complianc...

Lead the charge in system-level Verification & Validation for medical devices, focusing on planning, executing, and documentation to ensure compliance with FDA and ISO 13485 standards while collaborat...

Lead the design and operation of advanced data pipelines and products powering AI in Biopharma. Collaborate with cross-functional teams to streamline data integration, enhance product development, and...

Join a pioneering AI-native team to build and operate cutting-edge data pipelines that empower product development in biopharma, integrating diverse data systems to accelerate safe and effective drug...

Lead the charge in overseeing clinical studies to enhance organ preservation through innovative research and management strategies, ensuring compliance and data integrity across multiple protocols and...

Unlock your potential as a key leader in GxP auditing, driving compliance and quality oversight across computerized systems in regulated environments. Collaborate cross-functionally to enhance risk ma...

Transform packaging engineering processes to enhance quality and compliance while driving cost-saving initiatives and supporting new product development in a collaborative, innovative environment. Lea...

Join a dynamic team ensuring innovative catheter products meet quality standards through thorough regulatory compliance and cross-functional collaboration in all phases of development and manufacturin...

Optimize siRNA design and off-target assessment by integrating genomic data and machine learning. Collaborate with cross-functional teams to advance RNA-based therapeutics, ensuring safer and more sel...

Join a team that's dedicated to ensuring dietary supplement quality by executing robust QA GMP compliance processes. Your expertise will be pivotal in managing supplier quality and driving continuous...

Lead the charge in analytical development for radiopharmaceuticals, providing strategic oversight and collaborative support to ensure compliance with GMP and regulatory standards throughout product de...

Accelerate our quality assurance efforts by implementing and managing robust Quality Systems for GMP Manufacturing and Testing, ensuring compliance and fostering cross-functional collaboration across...

Help us provide strategic legal support in contracting across diverse functions, emphasizing R&D agreements. Manage negotiations, enhance workflows, and collaborate with stakeholders to mitigate risks...

Unlock potential by ensuring product quality and regulatory compliance in manufacturing. Lead cross-functional teams in CAPA management, root cause analysis, and continuous improvement initiatives, dr...

Transform the contract lifecycle process by drafting, negotiating, and administering agreements. Collaborate with stakeholders to ensure compliance and clarity in all contractual engagements, while su...

Unlock potential by driving technical sales in the gene therapy sphere, managing demos, and accelerating product adoption. Collaborate with Central Sales to convert opportunities and support long-term...

Transform regulatory strategies in oncology by leading global submissions, engaging with health agencies, and ensuring compliance with evolving regulations to secure market approvals for innovative mR...

Partner with us to enhance GCP quality systems across global clinical operations. You will drive compliance, lead risk assessments, and mentor teams to ensure excellence in decentralized trial activit...

Champion quality assurance initiatives by leading food safety and compliance efforts. Drive excellence across operations, develop effective quality cultures, and mentor teams to ensure adherence to st...

Transform aseptic quality assurance by leading a high-performing team, driving compliance through effective monitoring and training, and ensuring best practices in contamination control to deliver top...