Regulatory Affairs Executive Ahmedabad, .."R"

Regulatory Affairs Executive
Bonita Pharmaceuticals Private Limited -     Ahmedabad, Gujarat

Should have depth knowledge of Common Technical Dossier (CTD), ACTD and eCTD. Ensuring that a company's products comply with the regulations of Ministry of Health (MOH) for country specific Update colleagues and senior management periodically regarding the latest guidelines and important changes in regulatory requirements of countries that the company exporting to Collecting and evaluating scientific and technical data that has been researched by colleagues Preparing and compiling all technical documents for dossier Communicate with Ministry of Health (MOH) of country specific for dossier requirements Writing clear arguments and explanations for clarifications arising during product registration Preparing clear, accessible product labels and patient information leaflets Providing strategic advice to senior management throughout the development of a new product Undertaking and managing regulatory inspections if any Specifying storage, labeling and packaging requirements. Reporting to senior manager on daily basisCLICK HERE TOVIEW/ APPLY