Executive / Sr Executive/ AM - Regulatory Affairs US

Role & responsibilities

• Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidance 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

• Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.
• Good technical knowledge, review skills and understanding of regulatory submissions.
• Strong knowledge of CTD /eCTD requirements for submission of dossiers.
• Ability to try new approaches when faced with challenges.
• Should have good analytical and learning attitude.