Maneesha Ravula

Skills

ICH guidelines, FDA & EU
regulations
Data Quality and compliance Data Governance
Change controls, Gap analysis Global labeling
INDs, CTA’s
Regulatory Systems & Tools
Veeva Vault RIM Liquent Insight
TrackWise (QMS)
Redcap (CDM)
Microsoft office Viz. Word, Excel, PowerPoint, Power BI

About

Results-driven regulatory data management professional with over 10 years of experience with a strong understanding of global regulatory requirements and compliance frameworks in the pharmaceutical industry. Experienced in managing RIM systems to ensure accurate regulatory data for submissions, compliance, and lifecycle management. Adept at cross-functional collaboration with regulatory affairs, labeling, and quality teams to optimize data governance and decision-making. Committed to continuous learning and driving regulatory excellence in a dynamic environment.