Job title: Regulatory Affairs Executive
Company: Amico Formulations LLP
Job description: Regulatory Affairs Executive
Regulatory Affairs Executive Location : Masjid Bunder, Mumbai Experience : 5+ Yrs in Pharma Industry Must have experience in handling regulatory affairs for ROW market mainly Central and Latin America and Africa for Pharma Formulations. Preparation, Compilation & Review of Registration documents that include Administrative & Technical. Reviewing the technical documents provided by QA, QC, Production. Providing them the report of shortcomings & ensures them to correct the documents. Handling RFIs (Requested Further Informations) queries raised by Importer/Agent/Regulatory authorities during evaluation of technical data. Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation. Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies. Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames. Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner. Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team. Fill up customer questionnaires by collecting information from various concerned departments. You should be good in man – management & co – ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time. Maintenance of the complete history of each drug product
Expected salary: Rs.500000 – 600000 per year
Location: Mumbai, Maharashtra
Job date: Sun, 25 Sep 2022 22:05:10 GMT
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