Job Detail Page

Job Responsibilities:

 Ensure that a company's products comply with the regulations of the regions where they want to distribute them

 Preparation of dossiers

 Keep up to date with national and international legislation, guidelines and customer practices Collect, collate and evaluate scientific data from a range of sources

 Develop and write clear arguments and explanations for product license and renewals

 Submissions Whole sale license and renewals to strict deadlines

 Preparation documents for market tenures

 Knowledge on Sugam Portal and National single Window Portal

 Preparation of documents for Queries raised by Drug Authorities

 Undertake and manage regulatory inspections

 Review company practices and provide advice on changes to systems Liaise with, and make presentations to, regulatory authorities

 Monitor and set timelines for license variations and renewal approvals Liaise with, and make presentations to, regulatory authorities.