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Satya Prakash
Satya Prakash
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.
FORMERLY AT
Nexinfo
LOCATION
Banglore,India
AVAILABILITY
Full-time
Skills
Angular 11
Bootstrap
Chrome Developer Tools
CSS3
Eclipse
Firebug
HTML5
IE Developer Tools
Intellij
JavaScript
jQuery
JSON
Notepad++
React.js
Redux
+5 More
Work Experience
Senior Consultant – Regulatory Systems & Data Migration
Nexinfo (Client: Gilead Sciences, Bangalore)
Oct 2022 – Present
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Led data migration and validation of 4000+ regulatory specifications from Veeva Vault RIM to SAP S/4HANA, ensuring GxP compliance.
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Conducted medical and regulatory document reviews for submission completeness and readiness.
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Collaborated with global QA and Regulatory teams to ensure compliance with FDA, CE-MDR, and ISO standards.
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Authored and executed validation documents (IQ, OQ, PQ, DQ) aligning with regulatory expectations.
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Managed quality events (deviations, CRs, CAPAs, and audits) and performed risk management (ISO 14971).
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Supported clinical documentation review during Submission Content Planning (SCP) and RIM linking.
TECHNOLOGIES
Veeva Vault RIM/QMS | Lorenz docuBridge | Insight Publisher | Global Validator | ORION / GReAT | SQL / T-SQL | Tableau Prep | eCTD Xpress | SmartDesk | HP ALM | JIRA | Adobe Acrobat | MS Office Suite,Regulatory Submissions | Clinical & Medical Document Review | Data Migration & Validation | GxP & ISO 14971 Compliance | Risk Management | Quality Documentation | Audit Readiness | System Testing | Change Control | Team Leadership
Project Manager (Freelance)
Cinephile
Nov 2021 – Sep 2022
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Managed complete project lifecycle including planning, budgeting, and stakeholder coordination.
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Oversaw compliance documentation and vendor qualification aligned with quality systems.
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Ensured regulatory and operational workflow alignment across departments.
TECHNOLOGIES
Veeva Vault RIM/QMS | Lorenz docuBridge | Insight Publisher | Global Validator | ORION / GReAT | SQL / T-SQL | Tableau Prep | eCTD Xpress | SmartDesk | HP ALM | JIRA | Adobe Acrobat | MS Office Suite,Regulatory Submissions | Clinical & Medical Document Review | Data Migration & Validation | GxP & ISO 14971 Compliance | Risk Management | Quality Documentation | Audit Readiness | System Testing | Change Control
Senior Data Analyst – Regulatory & Clinical Data Management
Symphony Health Sciences
Aug 2014 – May 2021
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Conducted medical and clinical documentation reviews for global regulatory submissions.
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Managed Veeva Vault RIM workflows, linking Regulatory Objectives (ROs) and Submission Records (SRs).
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Supported submission content plans (SCP) and medical data validation for compliance and accuracy.
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Delivered data cleaning, mining, and validation across large datasets following GxP/HIPAA/HL7 guidelines.
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Trained global users on document management systems and ensured data integrity.
TECHNOLOGIES
Veeva Vault RIM/QMS | Lorenz docuBridge | Insight Publisher | Global Validator | ORION / GReAT | SQL / T-SQL | Tableau Prep | eCTD Xpress | SmartDesk | HP ALM | JIRA | Adobe Acrobat | MS Office Suite,Regulatory Submissions | Clinical & Medical Document Review | Data Migration & Validation | GxP & ISO 14971 Compliance | Risk Management | Quality Documentation | Audit Readiness | System Testing | Change Control | Team Leadership
