Officer / Sr Officer - Regulatory Affairs US Market

Unichem Laboratories; Mumbai; On-site; INR 4,50,000 - 6,75,000; Full time

Job summary

A pharmaceutical company in Mumbai seeks a qualified individual to author high-quality CMC documentation for US FDA submissions. The role involves identifying required documentation, reviewing content, and coordinating with stakeholders to ensure regulatory compliance. Candidates must possess a solid understanding of regulatory submissions, strong knowledge of CTD/eCTD requirements, and hands-on experience with eCTD software. Good analytical skills and a proactive approach are also essential.

Qualifications

• Hands on experience using eCTD software and attending e-publishing requirements throughout the project lifecycle.
• Good technical knowledge and review skills regarding regulatory submissions.
• Strong understanding of CTD/eCTD requirements for submitting dossiers.

Responsibilities

• Author high-quality CMC documentation for US FDA submissions.
• Identify required documentation for US regulatory submissions.
• Review and identify content and quality issues with source documents.
• Keep updated with regulatory guidelines and requirements.
• Coordinate with stakeholders to provide technical support.
• Contribute to the regulatory strategy and identify critical issues.

Skills

Hands on experience with eCTD software

Good technical knowledge

Strong CTD/eCTD knowledge

Analytical and learning attitude

Ability to try new approaches

Job description

Job 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.
• Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle

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.