Amneal Pharmaceuticals - Multiple Openings for Freshers & Experienced Candidates in Regulatory Affairs (OSD / INJ.)

Multiple Openings in Regulatory Affairs (OSD + INJ) @ Amneal

Dear Candidate, 

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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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