We Meliorate Health would like to introduce ourselves as a registered Healthcare product manufacturer in Mumbai India Our products are pharmaceutical formulation food supplementary products herbal products We aim to provide one stop service center for all our global partners for hospital medical needs We have a nutraceutical manufacturing facility at Ahmednagar Maharashtra To know more about us kindly go through our website www melioratehealth com We Meliorate Health are pleased to inform you that our company is offering Regulatory Affairs Executive designation to B Pharm M Pharm candidates Please read the JD mentioned below for more details about the role Designation Executive Regulatory Affairs Qualification B Pharma M Pharm Department Regulatory Affairs Location Goregaon East Mumbai Joining CTC Package around 3 00 lacs to 4 00 lacs per anum Job Responsibilities 1 Dossier Preparation Preparation and review of standard dossier ACTD CTD ECTD as per Country specific guideline 2 Query Response Response to all dossier related queries to comply the requirement from Ministry of Health of different countries or Regulatory team from different countries 3 FDA Department CO-ordinate with FDA documentation department to apply for product approvals COPPs FSCs or any tender documents 4 Co-ordination Co-ordination with plants for arranging samples and working standards from plant as per Authority requirement Co-ordination with Marketing Department and Export Department for various registration activities Co-ordination with the plant and R D for MFR and BMR required for dossier preparation 5 Recording Data Management Responsible for maintaining proper records and storing all dossiers as per company Guidelines Policies 6 Miscellaneous General After receipt of sample from plant further processing at HO for printing and dispatching of sample Developing art works for label carton and leaflet in co-ordination with artist designer Co-ordination with customer site for artwork finalization approval Ensuring orders to get manufacture as per approved artwork coordinate to get print proof pre shipment sample approval from customer Arranging market samples for new product required by ADL Department to prepare quality Data Work as a team with all Regulatory colleagues Supervising and reviewing documentation of dispatch samples and hard copy of dossiers Legal document MSDS Invoice Non-Hazardous certificate Covering letter Indemnity letter and proper packing of sample Supervising and reviewing of Administrative documents for Notarization Bombay chamber of commerce Legalization and apostille as per country specific Embassy Data Surfing related to Clinical non clinical pertaining to product as well as dossier requirement Job Types Full-time Permanent Pay 300 000 00 - 400 000 00 per year Advantages Commuter assistance Internet reimbursement Leave encashment Education Bachelor s Required Experience total work 1 year Required Location Goregaon East Mumbai Maharashtra Required Work Location In person
📌 Regulatory Affairs Executive (Maharashtra)
🏢 Meliorate Health
📍 Maharashtra
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