GM Regulatory Affaire ROW Market For Pharma Nagpur plant OSD

Job Description

D ossiers Planning, Allocation, Execution and Monitoring for timely submission to health agency for obtaining product and company registration in LATAM, APAC and CIS markets. • Managing the work delegation to the Regulatory Team & careful monitoring of the monthly submissions, filling of variation & registrations • Review of Dossiers in CTD, ACTD & Country specific format • Responsible for Query response & filling of product variation to the different health authorities • Review of SPC, Labeling & PIL • Review of validation protocol for proposed commercial batch sizes • Obtaining Product / Company registration through monitoring the regulatory requirements, maintaining online database & product lifecycle management • CRM, Scientific & Corporate Communications along with management of internal / external customers and various health agencies • Experienced Site/product Audit of Ukraine, Kazakhstan, Uganda, Malaysia, Philippines. neetij@selectsourceintl.com