PRASHANT SOLANKI
Gurugram
Summary
Regulatory Affairs and Quality Documentation professional with 14+ years of experience supporting pharmaceutical and consumer healthcare organizations across EU and emerging markets. Strong expertise in Quality Management Systems (QMS), regulatory submissions support, and controlled documentation lifecycle management in compliance with FDA, EMA, EU GMP, ICH, ISO, and GxP requirements. Hands-on experience with eQMS platforms (Veeva Vault, TrackWise), audit readiness, post-approval lifecycle management, and documentation remediation. Proven ability to work in client-facing, consulting-driven environments with strong technical writing and stakeholder management skills.
Overview
15
15
years of professional experience
Work History
Deputy Manager – Regulatory Affairs & Quality Documentation
WNS (a part of Capgemini)
Gurugram
04.2015 - Current
- Support global life sciences clients with regulatory and quality documentation in line with FDA, EMA, EU GMP, ICH, and ISO requirements.
- Author, review, and manage QualityDocs including SOPs, policies, work instructions, templates, and controlled records.
- Manage end-to-end document lifecycle using Veeva Quality Vault and Regulatory Vault, ensuring version control, approvals, and compliance.
- Perform Elemental Impurity Risk Assessments (ICH Q3D) and support broader risk management documentation.
- Support regulatory submissions and post-approval activities, including MA applications, variations, renewals, labeling updates, and withdrawals.
- Review Module 1 submission documents and respond to health authority queries.
- Actively support deviation management, CAPA documentation, and change control activities within eQMS.
- Provide audit readiness and inspection support, including documentation remediation during regulatory inspections.
- Serve as primary client liaison, coordinating with Regulatory, Quality, Manufacturing, R&D, and external partners.
- Contribute to process improvement, document standardization, and digital quality initiatives.
Research Associate – Regulatory Affairs
DDReg Pharma Pvt. Ltd.
Gurugram
05.2013 - 04.2015
- Supported regulatory submissions and lifecycle management for pharmaceutical products.
- Prepared and reviewed CMC documentation, GAP assessment reports, and post-approval applications (Type IA/IB – Europe).
- Compiled dossiers in NeeS format and supported responses to regulatory agency queries.
- Participated in change control and quality documentation activities using TrackWise QMS.
- Reviewed artworks and labeling as per country-specific regulatory requirements.
- Collaborated with cross-functional teams to ensure timely, compliant submissions.
Officer – Drug Regulatory Affairs
Psychotropics India Limited
Haridwar
04.2011 - 05.2013
- Reviewed and compiled CTD / ACTD dossiers for emerging markets (Asia, Africa).
- Reviewed technical and quality documents including validation reports, stability data, BMRs, specifications, DMFs, and COAs.
- Supported applications for CPP, WHO-GMP, site registration, and product approvals.
- Coordinated with QA, QC, Production, and country managers for regulatory submissions.
- Prepared and reviewed responses to regulatory authority and client queries.
Education
Master of Pharmacy (M.Pharm) - Pharmacology
Utkal University
Bhubaneswar01.2010
Bachelor of Pharmacy (B.Pharm) -
VNS Institute of Pharmacy
Bhopal01.2008
Skills
- Regulatory Affairs & Submissions
- CTD / eCTD dossier support
- Post-approval lifecycle management
- Regulatory intelligence
- Global regulatory compliance
- Quality Documentation & QMS
- SOPs
- Policies
- Work Instructions
- Templates
- Records
- Document lifecycle management in eQMS
- Deviation
- CAPA
- Change Control documentation
- Risk Management
- Audit and inspection readiness support
- Veeva Vault
- TrackWise
- LIMS
- MS Excel
- Power BI
- MS Office Suite
- Technical and regulatory writing
- Client and stakeholder engagement
- Cross-functional collaboration
- Process harmonization
- Project and team leadership
Languages
- English
- Hindi
Industry Exposure
- Pharmaceutical
- Consumer Healthcare
Regulatory Knowledge
- ICH Guidelines
- EU GMP
- ISO standards
Accomplishments
Received the Knight of KC award from the client in recognition of excellent project delivery
Timeline
Deputy Manager – Regulatory Affairs & Quality Documentation
WNS (a part of Capgemini)
04.2015 - Current
Research Associate – Regulatory Affairs
DDReg Pharma Pvt. Ltd.
05.2013 - 04.2015
Officer – Drug Regulatory Affairs
Psychotropics India Limited
04.2011 - 05.2013
Master of Pharmacy (M.Pharm) - Pharmacology
Utkal University
Bachelor of Pharmacy (B.Pharm) -
VNS Institute of Pharmacy