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-ordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective.
• Actively participate as a member by contributing to the regulatory strategy, identifying critical issues and lessons learned.

DESIRED SKILLS