DRA Profile - Please find below the job description as requested o Preparation of Dossier as per country guidelines ACTD CTD Country Specific format o Preparation of SmPC PIL Package insert as per country specific requirements o To review all documents related to dossier preparation such as Quality and administrative documents o To manage new registration re-registration query variation filing etc o Handling and resolving queries raised by MOH Customers within deadline o Ensuring that quality standards are met and submissions of dossiers meet strict deadlines o Reviewing labeling and labels for compliance with regulatory requirements o Artworks for dossier preparation o Working on Pre Post registration of dossier registration o To make a technical file for registered dossier o To coordinate with various departments such as quality assurance production quality control o Work on lifecycle management for compilation and record of all regulatory documents Job Type Full time Pay 24 000 00 - 25 000 00 per month Work Location In person

📌 Drug Regulatory Affairs (New Delhi)
🏢 Harasha Pharma
📍 New Delhi