Sr.Exe - Regulatory Affairs (Formulations),Chennai

Job Code

NM23041541

Position

Sr.Exe - Regulatory Affairs (Formulations)

Division

RA

Location

Chennai

Qualification

M.Pharm

Experience Required

4-6 years

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Job Description

  • Review & submission of approvable ANDAs / Registration of dossiers related to Orchid Healthcare’s (OHC) products across the globe, as per respective regulatory requirements of different countries.                                                                                                                     
  • Review and submission of responses to the queries from Regulatory Agencies.                                                                                                                        
  • Co-ordination with external Regulatory Agencies for regulatory submissions and approvals.                                                                                                                             
  • To prepare the schedule for Dossier submission and monthly report submission.                   
  • To train personnel’s on the awareness of International Regulatory guidelines ( on line Training). Building good team and motivating them in all direction.  Training team to prepare documents for National market Lic. Submission for manufacturing licenses, test licenses, CPP, cGMP certificates from Indian Drug control administration                                          
  • Co-ordination with inter and intra department to make available of the documents.                                                                                                                                                                                                                               
  • Preparation of budget for the departmental expenses and monitoring the same.                                                                                                                       
  • Regulatory feedback & updation on latest regulatory information to other departments.        Providing regulatory support to other department
  • Preparation checklists and SOP's for regulatory department activities. Tracking of dossiers submission till the Launch.