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  • Develop, implement, and monitor outcome-based reporting systems for high-risk diagnoses, patient groups, and care processes.
  • Collaborate with interdisciplinary teams to prepare quality reports for clinical departments and regulatory bodies.
  • Apply performance improvement methods like Lean Six Sigma and Rapid Cycle PDSA to enhance patient care outcomes.

Cooper University Health Care is a leading healthcare provider committed to extraordinary care and clinical innovation. With a large team of professionals, it offers competitive benefits and opportunities for career growth.

  • Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
  • Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
  • Support regulatory team in preparing documents for study submissions and participate in feasibility research.

PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.

  • Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
  • Manage essential document collection, informed consent customization, and maintain project plans and trackers.
  • Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.

We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.

  • Manage site activation and regulatory submissions for clinical trials in Spain.
  • Oversee contract and budget negotiations with sites to ensure timely approvals.
  • Collaborate with cross-functional teams to maintain project documentation and timelines.

Precision for Medicine is a global Clinical Research Organization specializing in precision medicine for rare diseases and oncology. The company is experiencing continued growth and values operational excellence and regulatory expertise.

  • Prepare, review, and coordinate local Ethics Committee and regulatory submissions for clinical studies.
  • Collaborate with internal teams and study sites to align site start-up activities and ensure timely submissions.
  • Maintain accurate trial status information, local files, and current knowledge of applicable procedures and regulations.