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Amneal Pharmaceuticals
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Manager, Regulatory Affairs | Post Approval | US Market

Manager, Regulatory Affairs | Post Approval | US Market

Amneal Pharmaceuticals

11 - 16 years

35 - 40 Lacs

Ahmedabad

Posted:1 month ago| Platform:

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Skills Required

USFDA Team management Anda Manufacturing process Manager Regulatory Affairs Quality Review ICH

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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Manager, Regulatory Affairs | Post Approval | US Market