Phone: +91 7680051100 

RA Lead - US Market

Posted On: Tuesday, 6th February 2018
Category: Pharmaceutical
Department: Regulatory Affairs (RA)
Location: Hosur
Pay Rate: 6,00,000 - 8,00.000
Duration: 6 - 8 Years

Job Description:

Preparation and review of ANDA Dossier Modules for USFDA

Preparation and review of Post Approval changes for USFDA.

Review of Validation Packages of ANDA submissions to regulatory agencies.

Responding to deficiencies of ANDAs posed by the Regulatory Agencies.

Review and approval of documents such as BMR’s, BPR’s, Raw Material/Finished Product Specifications & STP’s, CoA’s, stability protocols and reports for regulatory compliance.

Review and approval of validation protocols and reports of Analytical and Microbial methods for regulatory compliance.

Review of Drug Master File received from vendors for evaluating on regulatory compliance.

Review of documents related to Test, No Objection Certificate, Manufacturing and Import licenses applying or renewal

Review and approval of specifications and its justification 

Preferred Skills:

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