 |
Aurobindo Pharma Ltd Job Opening For Any Graduate - Regulatory Affairs |
Hiring for Documentation Regulatory Affairs for US Injectable.
Interested can send across your updated resume to rakesh.maganti@aurobindo.com
Kindly mention US Documentation in
subject.
1 Planning and pubishing of high quality regulatory submissions to regulatory authorities
2. Preparation of documents as per eCTD and Portable Document Format speifications to
support in filing
3.Compliance che cking, toc linking, Bookmarking, Rendering Multiple Documents to
PDF, Creation of external inks, tagging of files as per eCTD requirement.
4 Drug listing after NDC reservation
5 Well versed with Computers (Ex. MS Office, PDF, ISI writer etc) with high speed typing skill
6.Experience in handling software like PharmaReady, eCTD submission valid ation tools viz Lorere.
7.
a) Initial & subsequent submission Sequence creation (Module 123 &5)
b) SPL Preparation & troubles hoot the SPL errors if any)
8.Ability to manage workdoad capacity with ever changing deadlines/requirements with ability8
to assist & support other members of the team where required.
9 Actively participate in development, review and process improvement activities
10 Good knowledge of eCTD guidelinesGood undestanding of existing regulatory agency standards and formats for submission11
and ensure that the CMC publishing output meets the se requirements
Education :Any Graduation
Experienced :4-7 Years
Post a Comment