Regulatory Affairs Officer
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Highly motivated and detail-oriented M.Pharm (Pharmacology) graduate with hands-on experience as a Regulatory Officer in the pharmaceutical industry. Proficient in pharmacovigilance, clinical and preclinical research, regulatory documentation (CTD/ACTD/NPI), and adverse drug reaction (ADR) reporting. Skilled in data analysis, manuscript preparation, dossier compilation, and risk management plans.
Certified in GCP and Clinical Research with additional expertise in in-silico modeling and animal studies. Strong interpersonal and communication skills with a keen interest in contributing to the healthcare sector through safety monitoring, regulatory compliance, and evidence-based research.
A highly motivated and detail-oriented individual with strong skills in pharmacovigilance, regulatory documentation, and clinical research processes. Skilled in preparing regulatory submissions such as CTD/ACTD dossiers, PSURs, Risk Management Plans, and ADR reporting. Well-versed in data analysis, documentation standards, and compliance with national and international pharmaceutical regulations.
Proficient in scientific writing, research methodologies, and safety monitoring, with a strong commitment to quality and patient safety.
Completed M.Pharm in Pharmacology from MET’s Institute of Pharmacy, affiliated with Savitribai Phule Pune University, achieving a CGPA of 8.57. Academic training focused on pharmacological research, regulatory science, clinical trial processes, and drug safety. Gained practical knowledge through research projects, certifications in Good Clinical Practices (GCP), and coursework related to clinical research, regulatory affairs, and pharmacovigilance.
