Amneal Pharmaceuticals walk-in interview for Freshers and Experienced candidates -; Regulatory Affairs - Pharma Jobs and Pharma Walk-in interviews | Pharmawalks
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Friday, November 22, 2019

Amneal Pharmaceuticals walk-in interview for Freshers and Experienced candidates -; Regulatory Affairs

Amneal Pharmaceuticals walk-in interview for Freshers and Experienced candidates -; Regulatory Affairs
Multiple Openings in Regulatory Affairs (OSD + Injectable) @ Amneal Pharmaceuticals
Dear Candidate, 
This is an auto generated mail. So please ignore if it doesn't match with your current role.
We are having multiple positions in Regulatory Affairs for US Market.
Department: Regulatory Affairs
Designation: Executive / Sr. Executive
Experience: 2 - 10 Years
Job Location: Ahmedabad
Required Candidate Profile:
👉 Must have exposure of US market.
👉 Good communication skills
👉 Fresher may also apply.
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.

Interested candidates can send their profile to pujas@amnealindia.com

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