Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.

· Submission of technical data package and Applicant’s Part for semi-regulated markets

· Submission of response to deficiencies received from authorities and customers

· Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets

· Use of eCTD software’s and submission gateways like ESG & CESP

· Providing regulatory inputs in early development phase of APIs

· Review of change controls and technical data required for DMF submissions

· Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF

· Preparation of LOA and commitment and data management

· Submission of change notification for customer.

· Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps

· Maintenance of database for regulatory submissions including customer notifications

· Well versed with current regulatory guidelines.