
Sr Exe
3 weeks ago
Job Summary Regulatory submission of new products renewals variations response to queries and Life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals Area of Responsibility 1 New submissions Renewals a Review prepare CMC Chemistry Manufacturing and Controls dossiers for fresh submissions b Review documents Development report scale up report specification stability protocol artworks etc before initiation of Exhibitbatches for adequacy 2 Approval Review prepare response to deficiency enabling approval of products filed to regulatory agency 3 Lifecycle management for drug formulations a Prepare and review variations as per the country specific requirements to support approval of changes such as API vendor changes changes in ROS test parameters DF site changes harmonization of products etc 4 Regulatory compliance a Prepare Review and circulate approval package with product history sheet to stake holders upon receipt of approval and updatethe same based on queries and variations b Ensure reposition of comprehensive product information into central repository C Review regulatory filing impact of variations change controls etc Geographic Scope Market MENA-GCC UAE Oman Saudi Arabia Egypt Iran Iraq Bahrain etc
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Sr Exe
2 weeks ago
Vadodara, Gujarat, India Vodafone Full timeVOIS Intro About VOIS VOIS Vodafone Intelligent Solutions is a strategic arm of Vodafone Group Plc creating value and enhancing quality and efficiency across 28 countries and operating from 7 locations Albania Egypt Hungary India Romania Spain and the UK Over 29 000 highly skilled individuals are dedicated to being Vodafone Group s partner of...
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Urgent Sr Exe
10 hours ago
Vadodara, Gujarat, India Sun Pharmaceutical Industries Full timeCompilation review of dossier for US EU AU Canada IL market for both solid oral and non-oral dosage form Review of query response prepared and compiled by regulatory associates Manage all the activities pertaining to dossier submission for aforesaid markets Meet the dossier submission and query response timeline as per given target Review of all...
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Executive
3 days ago
Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time**Position**: Exe / Sr. Exe (Regulatory Affairs, Baroda) **Grade **- G12A/G11B **Education** - B.Pharm / M. Pharm **Experience** - 4 to 6 years **Location** - R&D - Baroda - Review all data and documents related to product registrations for various health authorities. - Compile registration dossiers for submission to various health authorities like -...
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Executive
3 days ago
Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time**Title**:EXECUTIVE**: - Date: Sep 3, 2024- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd**Position**: Exe / Sr. Exe (Regulatory Affairs, Baroda) **Grade **- G12A/G11B **Education** - B.Pharm / M. Pharm **Experience** - 4 to 6 years **Location** - R&D - Baroda - Review all data and documents related to product registrations for...
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Vadodara, Ahmedabad, Surat, India D Tech Management Resource Full timeJob DescriptionRole & Responsibilities- Handle dealers and distributors; B2B or B2C retail experience acceptable.- Understand the requirements of contractors and support their needs.- Conduct regular customer visits and product trials.- Address and convey technical queries to clients effectively.- Meet with contractors to understand project-specific...