Regulatory Submission Publisher
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Publishing and submission of IND SAE in eCTD format. Performing Promotional labelling (PRA) submissions. (including Pre-submissions) FDA Submissions via USFDA ESG gateway i.e. IND, NDA, BLA.
EU Submissions via CESP gateway, EMA gateway and non-gateways submissions i.e. CP, NP, DCP & MRP. Publishing of submissions for GCC (Gulf) region and validating them as per GCC guidelines & requirements
Compiling documents using e-CTDXpress and cross-reviewing. Generating output in CTD format by using ISI Publisher tool. Creating STFs and assigning documents as per Med watch, AoSE, Cover letter and Application forms(FDA 1571, 356h, 2253 etc). Reserving eCTD sequences prior to addition of documents and cross-checking it. Validation of compiled output by Lorenz e-Validator. Performing Peer Review and QC check before submissions.
Document Publishing of Clinical Study Report (CSR), Risk Management plan (RMP), BD Vdoc, Response Vdoc, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Licence Renewals Safety Reports, Periodic Adverse Drug Experience Report (PADER). Safety Summary Reports (SSR), All clinical and safety Documents.
Creating Vdoc and Hyperlinking activity for creating external links and reviewing as per Submission Ready Standards & requirements; specifically CSR linking.
Clinical Trial Transparency (CTT) Documents publishing, Publishing of Redacted Documents as per CTT Submission Ready Standards & requirements.
Publishing and submission of IND SAE in eCTD format. Performing Promotional labelling (PRA) submissions. (including Pre-submissions) FDA Submissions via USFDA ESG gateway i.e. IND, NDA, BLA.
EU Submissions via CESP gateway, EMA gateway and non-gateways submissions i.e. CP, NP, DCP & MRP. Publishing of submissions for GCC (Gulf) region and validating them as per GCC guidelines & requirements
Compiling documents using e-CTDXpress and cross-reviewing. Generating output in CTD format by using ISI Publisher tool. Creating STFs and assigning documents as per Med watch, AoSE, Cover letter and Application forms(FDA 1571, 356h, 2253 etc). Reserving eCTD sequences prior to addition of documents and cross-checking it. Validation of compiled output by Lorenz e-Validator. Performing Peer Review and QC check before submissions.
Document Publishing of Clinical Study Report (CSR), Risk Management plan (RMP), BD Vdoc, Response Vdoc, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Licence Renewals Safety Reports, Periodic Adverse Drug Experience Report (PADER). Safety Summary Reports (SSR), All clinical and safety Documents.
Creating Vdoc and Hyperlinking activity for creating external links and reviewing as per Submission Ready Standards & requirements; specifically CSR linking.
Clinical Trial Transparency (CTT) Documents publishing, Publishing of Redacted Documents as per CTT Submission Ready Standards & requirements.
I have Completed my bachelor of pharmacy from Gahlot college mumbai university
