Amneal Pharmaceuticals - Multiple Openings for Freshers & Experienced Candidates

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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