Multiple Openings in Regulatory Affairs (OSD + INJ) @ Amneal
Dear Candidate,
This is an auto generated mail. So please ignore if it
doesn't match with your current role.
We are having multiple opening in Regulatory Affairs for US
market.
Please find below the details:
Designation: Exe / Sr. Exe
Exp: 2-10 Yrs
Job Location: Ahmedabad (Corporate Office)
Job Details:
1. ANDA (Pre
Approval) :
· ANDA
Submission- Original and amendment
· Knowledge of
RTR and other FDA guidances.
· DMF Review
· Review and
evaluation of change controls and deviations status.
· Experience
of US market.
· Must be from
Oral Solid background.
2. Post-Approval:
· Post-Approval submission for US market
· Annual reports and supplements compilation,
preliminary evaluation of change controls and deviations status
· Cordination
with plant for day-to-day work
3. Regulatory
Operations:
· RO
submission document level publishing and quality checking.
· Review of
PDF files
· Checking of
PDF quality such as legibility and OCR
· Providing of
bookmarks, hyperlinks and generation of Table of content using ISI toolbox.
· eCTD
publishing.
Please share your resume at pujas@amnealindia.com in case
you are interested to change your job.
Required Candidate profile
· Must have
exposure of US market
· Good
Communication Skills.
· Freshers may
apply.
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