Regulatory Affairs Specialist Jobs in Westborough, MA

Manage regulatory strategies for AI-enabled medical imaging software, ensuring compliance across FDA and EU markets. Collaborate with cross-functional teams to facilitate submissions and lifecycle man...

Support the evolution of RNA and LNP manufacturing processes, contributing hands-on to the production of preclinical drug substances. Collaborate cross-functionally while ensuring high-quality outputs...

Champion compliance and innovation in sterility assurance, collaborating cross-functionally to support regulatory mandates and ensure product safety and efficacy through sterilization processes in man...

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

Explore opportunities as a Clinical & Regulatory Information Management SME, supporting client delivery across VeevaRIM and Clinical initiatives. Engage with stakeholders, optimize processes, and enha...

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...

Empower quality assurance by driving compliance in investigations and product quality. Collaborate across departments to enhance Good Laboratory Practices and maintain rigorous quality metrics. Elevat...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

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

Take ownership of validation activities for GMP equipment, ensuring compliance through protocol execution, documentation, and regulatory support while collaborating with cross-functional teams to enha...

Shape the future of medical information by serving as a key expert in a dynamic role that combines your scientific expertise with technology and content development to ensure high-quality responses fo...

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...

Collaborate with cross-functional teams to lead regulatory writing efforts, ensuring high-quality documentation throughout the drug development lifecycle, from preclinical to registration stages, to s...

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...

Drive clinical excellence by overseeing site management and monitoring for biotech and pharmaceutical projects, ensuring compliance and accuracy in clinical research data. Join us to impact lives thro...

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...

Drive impactful medical writing by leading regulatory documentation projects, ensuring clarity and compliance with standards, while collaborating across teams to deliver exceptional results and foster...

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...

Empower regulatory compliance within the 340B Program by interpreting complex regulations, advising internal teams, and ensuring operational readiness. Drive impactful educational initiatives and coll...