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

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.