Hire Talented Regulatory Medical Reviewer

Manager – Combination Product Quality Complaints

Dedicated Quality and Clinical Compliance professional with 13+ years of experience in the pharmaceutical and biologics sectors, specializing in Quality Assurance (QA), Quality Management Systems (QMS), and clinical/medical review of product complaints and investigations. Expertise spans across injectables, OSD, biologics, and medical devices, ensuring global regulatory compliance (USFDA, EMA, TGA, WHO, ANVISA). Skilled in CAPA management, deviation investigation, process validation, and data integrity (ALCOA+), with a strong background in clinical safety evaluation, audit readiness, and team leadership.

Clinical Trial Lead / Medical Reviewer

Accomplished Clinical Research and Medical Review professional with over 11 years of experience managing global Phase II–IV clinical trials across multiple therapeutic areas, including Oncology, Psychiatry, Cardiology, Neurology, and Autoimmune Disorders. Proven expertise in clinical operations, medical and data review, protocol compliance, and regulatory coordination. Strong command of GCP guidelines, audit readiness, and cross-functional collaboration with global regulatory and medical teams. Adept at site oversight, quality documentation, risk mitigation, and study leadership from start-up to closeout.

Senior Consultant – Regulatory Systems & Data Migration

Seasoned Regulatory Affairs and Clinical Documentation Specialist with 13+ years of experience in the pharmaceutical and healthcare industries, specializing in regulatory submissions, data management, document control, and quality compliance under GxP and ISO 14971 standards. Demonstrated expertise in Veeva Vault RIM/QMS, regulatory data migration, validation testing (IQ/OQ/PQ/DQ), and clinical document review for global health authority submissions. Skilled in audit readiness, risk management, and end-to-end regulatory documentation lifecycle management with cross-functional collaboration across QA, Regulatory, and Medical Affairs teams.

Sonal Kadam

Accomplished Pharmacovigilance and Clinical Safety professional with 12+ years of global experience across drug safety, signal detection, medical data review, and regulatory compliance in US, EU, and APAC markets. Skilled in ICSR case processing, MedDRA/WHODD coding, quality review, audit readiness, and risk management. Proven expertise in managing end-to-end safety operations, collaborating across regulatory, medical, and quality teams, and maintaining adherence to FDA, EMA, and MHRA reporting standards.

Senior Clinical Trials Lead / Medical Reviewer

Accomplished Clinical Research and Medical Review professional with 12+ years of global experience across Phase I–IV clinical trials. Proven expertise in clinical trial leadership, medical and data review, protocol evaluation, and regulatory submissions. Skilled in data accuracy assurance, patient safety evaluation, and GCP/ICH compliance. Adept at cross-functional collaboration, risk-based monitoring, and audit readiness, ensuring high-quality outcomes and scientific excellence across multiple therapeutic domains including Oncology, Cardiology, Neurology, and Autoimmune Disorders.