V Mohan
Lead Business Analyst @ CGI
About
Experienced Regulatory Affairs professional with 8+ years of expertise supporting global regulatory submissions across the entire product lifecycle. Adept in FDA and international regulatory documentation, including clinical protocols, clinical study reports, and end‑to‑end regulatory publishing. Possess a strong background in quality systems, audit and inspection readiness, labeling review, and cross‑functional regulatory collaboration. Known for effectively managing complex regulatory repositories, supporting global health authority inspections, and ensuring sustained compliance with evolving regulatory requirements. Highly proficient in Veeva Vault, regulatory data migration, and maintenance of audit‑ready documentation, enabling streamlined regulatory operations and risk‑based compliance. Recognized for a detail‑oriented, collaborative approach and the ability to support regulatory strategy through accurate, timely, and compliant documentation.
India
Bengaluru
Information Technology & Services
Data Analysis, Cross-functional Team Leadership, Leadership Development, Scientific Writing, Microsoft Excel, Microsoft Word, Psychology, Clinical Terminology, Publishing, Publications, Leadership Essentials, Scrum, Self motivator, Native Speaker, Project Management, Electronic Common Technical Document (eCTD), Regulatory Submissions, Veeva Vault, Sprints, Agile Methodologies
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