• Extensive knowledge of applicable government regulations. • Ability to inform and educate managers and department heads on regulations and policies • that require compliance. • Excellent written and verbal communication skills. • Excellent analytical and problem-solving skills. • Excellent strategic planning skills. • Proficient with applicable database and compliance software. • Proficient with Microsoft Office Suite or similar software. • To prepares New, Renewal dossier and variations (Site/ Formula) of South Asia, • LATAM countries and having specific knowledge for China, South Africa, Mexico and • Brazil filing and Regulatory knowledge of Guidelines viz, ICH, FDA PICs etc. • To review accuracy of executed data before submission - Plant generated validation • reports and raw data as required to ensure compliance before Dossier submission. • To review of documents for adequacy and accuracy. • To ensure regulatory compliance and liaison with countries / regulatory authorities during • the product registration process. • To arrange the samples as per country requirements. • Dossier Preparation, Verification & Filing to the authority (CTD, ACTD, Tech Park & • Country Specific) • TO get FSC, COO from the local authorities • Domestic FSSAI, Product Liasioning, MFG Licensing/liasioning • Compilation of dossiers in CTD, eCTD & national formats for Africa/China/CIS/ • Latam/ AU-NZ markets (eCTD Dossier) / any other emerging market countries. • Compilation and submission of queries and variations. • Review of documents, artworks • Review of change controls • Gap analysis for new product filing • Maintaining product Life cycle
