Officer / Executive Regulatory Affairs (e-CTD Publishing)

2 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Amneal Pharmaceuticals LLC

time outline icon Ahmedabad, Gujarat, India

Posted on 27-07-2021

1 Vacancy

Description

Regulatory Affairs (e-CTD Publishing)-US Market.
CTD/e-CTD compilation, publishing, validation for US and EU Submissions.
QC Check of PDF Files as per internal Regulatory Operations MaPP.
Update the eCTD tracking sheet after uploading the documents.
Archival and life cycle management of the e-CTD submission.
Priority Management. Understand criticality of any given tasks and discuss any identified issues with RO Group Lead.
Submission level publishing of PDF file like Uploading to eCTDXpress,
External linking, Compilation, Validation and Submission to ESG Gateway.
PDF Document check as per PDF specification required for US FDA requirements.
Quality work for all assigned publishing and review task by Group lead.
Well aware about the possible FDA eCTD related deficiency and focusing on preventing them with goal of no eCTD deficiency in every submission project.
Co-ordinate with RA CMC project manager for submission data and their timely submission to Agency.
Active involvement in all the group activities and support to team member for routine work to accomplish the targeted submission.