Research Scientist - USFDA

One of our leading Pharma based Clients in Roorkee is looking for Research Scientists who has good work experience in US Drug Regulatory Affairs.

Designation: Research Scientist

Experience: 5 - 8 Years

Location: Roorkee, Uttarakhand

Job Responsibilities:

- To provide documentation support to corporate regulatory team for timely submission of dossiers / amendments / supplements by providing quality documents.

- To review the plant documents like specifications, BMRs, BPRs, Stability protocols, hold time protocols, validation protocols and reports etc.

- To review the quality documents like Deviations, APQRs, Change Controls and incident reports raised during the manufacturing operation.

- To ensure the regulatory compliance is maintained in the plant in-line with the filed dossiers and post approval commitments.

- Apply the manufacturing licenses, GMP certificate, FSC and COPPs for drug products from the state FDA (Uttarakhand) 

- To review of code to code material transfer with in plant.

- To review the document intended to regulatory submission like analytical documents, stability data, BMR and BPR etc.

- In absence, designated deputy shall assume the responsibility.

- To perform additional responsibility assigned by HOD.

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