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