Regulatory Affairs US- Executive / Sr Executive

Experience - 5- 11 Years

Qualification- B. Pharm / M. Pharm

RESPONSIBILITIES

• Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance.

• Identify the required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.

• Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively.

• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.

• Co-ordinatio...

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