Drug Regulatory Affairs CTD Export Foreign Trade Bulk Drugs Technical Documentation Government Liasioning Dossiers regulatory affairs registration
Experience
1 to 4 Years
Industry
Pharma / Biotech / Life Science
Functional Area
Medical Professional / Healthcare Practitioner / Technician
Preparation, Review and submission of Technical documents/Dossiers (CTD/eCTD) related to Regulatory affairs for third country Export of Pharmaceuticals Formulations. Preparation and Review of SOPs. Compilation of Validation Protocols/Reports. Preparation, Review, Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for-Registration for import of pharmaceuticals Formulations and bulk drugs. -Import Licenses-Export Licenses-Manufacturing & Marketing licenses -WHO-GMP Certification-No Objection Certificates etc. Liasioning with DCGI/CDSCO/state FDA offices/Directorate General of Foreign Trade /FICCI/PHD Chamber of Commerce etc.