Qualification : B. Pharm/M. Pharm
• Preparation and submission of dossiers as per countries assigned specifically for EU Market.
• Preparation and Compilation of Module 1,2,3,4 and 5 for Europe Market in CTD/eCTD format.
• To handle inquiries and queries from Regulatory Authorities related to Quality, Clinical, Non Clinical, Bioequivalence and Product Registration.
• Submission of Registration Dossiers in EU, Semi-Regulatory and Emerging market.
• FDA related work- Application of COPP, Legalization of Documents through different embassies.
• Co-ordinate with departments, Manufacturing, Product Development, QA/QC, R&D, Legal, purchase etc. to ensure availability of documents and samples for EU submission.
• To check, review and prepare Artworks, Labels and Pack-inserts in co-ordination with Art department and printers for domestic and international markets.
• To verify for completes of documents such as Process Validation, Product development. records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers.
• Response of queries and other requirements as required by respective regulatory authorities in a stipulated timeframe.
• To prepare CTD & ACTD dossier. (Southeast Asia, Middle East countries)
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