location_onGurugram, Haryana, India
watch_later Posted: Jan 17, 2025
Job Description
Skills:
DMF, ICH, DRUG MASTER FILE, API, Preparation of LOA, Use of eCTD software’s,
Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.
Submission of technical data package and Applicants 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 softwares 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.
DMF, ICH, DRUG MASTER FILE, API, Preparation of LOA, Use of eCTD software’s,
Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.
Submission of technical data package and Applicants 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 softwares 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.
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