Executive / Senior Executive - Regulatory Affairs Department (RAD)

Job Description

Role & responsibilities of API - Regulatory Affairs Executive: *Responsible for new DMF submissions globally as per the market requirement. *Ensure to submit responses / Life Cycle Management. *Evaluation of Change Controls. *Responsible for New /revision of pharmacopeial monographs changes updating in DMFs / CEPs/ communication to CFTs and customers. *Smooth co-ordinate with cross functional team (CFTs) to get the required data for regulatory submissions in timely manner. *Ensure to submit all pre/ post change notifications with appropriate documents / Sections to customers well in time. *Coordinating with marketing department / internal formulation for smooth regulatory filings in timely manner.