Prepare necessary & supporting all documents (compiling) for submitting to Directorate General of Drug Administration (DGDA), Drug Testing Laboratories (DTL) and Narcotics like- cover letter, recipe, inclusion paper, annexure, stability data, price fixation & re-fixation, block list, drug clearance, import registration etc.
Pursue and take necessary steps for obtaining drug manufacturing license and whole sales drug license for sales depot from DGDA and its renewal on time.
Submit recipe, inclusion paper, stability data & annexure to DGDA for registration of new product.
Arrange inspection by DGDAs & narcotics in coordination with the respective department.
Prepare block list for submitting to DGDA for approval, amendment & its drug clearance.
Submit product price to DGDA for approval price and re-fixation price.
Take necessary steps to product renewal, annexure amendment, product specification change, pack size change etc.
Pursue and obtain for import product registration and its renewal on time.
Submit printed promotional material & add material to DGDA for approval.
Supervision of drug regulatory affairs that relates to DGDA, Drug Testing Laboratories (DTL) and Department of Narcotics etc.
Communicate & coordinate with other departments like- PMD, Production, QA&QC, PD, Engineering, Commercial, Accounts, Administration etc.
Communicate with toll manufacturing company as & when required.
Foster effective supervision and coordination amongst the staff of the department of drug regulatory affairs of Nipa Pharma.
Perform other duties and responsibilities as & when will be asked for from time to time by the authority.
New products information obtained from the DGDA.
Preparation & Submission of Block List and Yearly
Production Statement to Drug Administration.
To handle all Drugs and Narcotics related activities.