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M. Pharm Postgraduate specializing in Pharmaceutics with eCTD/ACTD Dossier Management expertise
Talent
New DelhiMember since August 25, 2026
PythoneCTD/ACTD dossier managementLabelingClinical documentationICH Guidelines
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PythoneCTD/ACTD dossier managementLabelingClinical documentationICH Guidelines
About
Dedicated M. Pharm postgraduate specializing in Pharmaceutics with practical exposure to eCTD/ACTD dossier management. Committed to supporting global regulatory filings through proficiency in CMC, labeling, and clinical documentation.
Experience
Regulatory Affairs Intern - DDReg Pharma Pvt. Ltd. - Gurgaon
(2025-07 - 2026-02)
- Dossier Management Lifecycle: Involved in the structured compilation and review of comprehensive dossiers (Modules 1–5) for international markets.
- Quality & CMC Review (M3): Assisted in the technical assessment of Module 3 data, including stability profiles and manufacturing process validation.
- Regulatory Compliance (M4/M5): Streamlined Clinical and Non-clinical reports ensuring data integrity and strict adherence to ICH Guidelines.
- eCTD Operations Support: Facilitated electronic submission tasks, including technical hyperlinking, bookmarking, and sequence validation.
- Regional Labeling (M1): Drafted administrative documents for Module 1 and updated SmPC/PIL as per regional regulatory requirements.
- Technical Data Collation: Collaborated with cross-functional teams to gather Bioequivalence (BE) data for dossier integration.
Education
M.Pharm - Pharmaceutics - LIMT, Greater Noida (2024 - 2024)
B. Pharm - PDM University, Bahadurgarh (2020 - 2024)
