Executive / Senior Executive - Regulatory Affairs (US Market)

2 weeks ago

Mumbai, Maharashtra, India Unichem Laboratories Limited Full time

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.
  • Coordination 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.
KEY SKILLS and COMPETENCIES

  • Hands on experience on using eCTD software and attending epublishing 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.

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