Sonal J.

Key Skills

Software

Other

Don't disclose

Top Subject Matter

Clinical & regulatory documents (eCTD, archiving)

Clinical study records and electronic archiving (metadata extraction)

Regulatory dossiers and secondary data search for crop protection products

Top Data Types

Document

Text

Top Task Types

Text Generation

Data Collection

Freelancer Overview

Regulatory Affairs Specialist focused on document preparation, metadata/quality checks, and electronic archiving workflo. Brings 13+ years of professional experience across complex professional workflows, research, and quality-focused execution. Core strengths include Documentum, SharePoint Online, and Other. Education includes Master of Science, Jamia Hamdard (2014) and Bachelor of Science (Honours), Amity University (2012). AI-training focus includes data types such as Document and labeling workflows including Text Generation and Data Collection.

Labeling Experience

Manager / Associate leadership for R&D Document Management with LLM/automation-enabled metadata extraction

DocumentText Generation

Led AI-augmented legacy document migration for centralized repositories by using Power Automate and GPT Personas to extract metadata from document content. Drove future-state AI strategy to simplify and accelerate document migration timelines and quality checks for new team members. Ensured successful, compliant handling of electronic archiving and records management aligned to global GxP standards. • Pioneered Power Automate and GPT Personas for metadata extraction during legacy migrations. • Implemented AI-driven efficiencies to meet strategic migration deadlines. • Established RIM support capabilities and coached teams on complex RIM workflows. • Applied clinical and regulatory document structure knowledge to support compliant archiving.

2021 - Present

Regulatory Affairs Specialist focused on document preparation, metadata/quality checks, and electronic archiving workflows

DocumentText Generation

Managed and validated clinical regulatory document sets for archiving, including eCTD electronic submission quality checks and document library maintenance. Applied domain knowledge to ensure document completeness and correct metadata handling for downstream processing. Supported electronic archiving workflows that rely on structured document content quality. • Ensured proper filing and assembly of registration technical documents in Documentum. • Performed quality checks for eCTD electronic submission documents. • Managed stakeholder requests and SharePoint-based archiving tasks. • Mentored and trained team members on document management practices.

2017 - 2021

Regulatory Affairs Specialist (document processing and metadata extraction for clinical records)

Don't discloseDocumentText Generation

Contributed to document processing and metadata extraction for clinical study records within a document management system. Performed electronic archiving activities requiring extraction and organization of text-based clinical information. Supported downstream retrieval and record management through structured handling of study documents. • Conducted metadata extraction for electronic archiving of clinical study records. • Processed clinical study documentation within a document management system. • Supported organization of archived records for future access.

2015 - 2017

Assistant Officer - Regulatory Affairs supporting dossier compilation and data search

OtherDocumentData Collection

Compiled registration dossiers and conducted secondary data searches to support regulatory submissions. Performed information gathering that feeds into structured dossier creation and later archiving workflows. Translated gathered information into organized regulatory dossier components. • Compiled dossiers for registration of crop protection products. • Conducted secondary data searches to support dossier preparation. • Prepared organized inputs for regulatory documentation workflows.

2014 - 2015

Education

Work History