Regulatory Affairs ''A''

Officer - Regulatory Affairs 

Preparation and Execution of Drug Master files of API in CTD and ECTD format, independently in coordination with plant people as per respective guidelines of countries as per target date set by management. Checking and reviewing of documents required for DMF filing received from plant for its . thoroughness and getting corrections done from plant , independently. Handling to DMF 

• deficiencies [ Preparation of action plan and deficiency responses] Timely .
• Response of DMF deficiencies in coordination from RD, Plant , ADD .
• Preparation of technical packages on API products for customers as per International marketing
• requirement , independently .
• Annual updates of DMF and renewal applications for CEP .
• Helping API plants for the preparation of audits from Regulatory Agencies, in case required.
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