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Amneal Pharmaceuticals logo
Senior Regulatory Affairs Specialist
Amneal Pharmaceuticals

0.0 years

0 Lacs

Ahmedabad, Gujarat, India

On-site

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF review with respect to USFDA regulatory requirement. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Drafting of the Annual Report with required submission data as per USFDA guidance. Preliminary review of entire submission package. Dra...

Posted 1 week ago

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