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Officer / Sr Officer - Regulatory Affairs US Market
Unichem Laboratories
Mumbai
On-site
INR 450,000 - 675,000
Yesterday
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Officer / Sr Officer - Regulatory Affairs US Market
Unichem Laboratories
Mumbai
On-site
INR 4,50,000 - 6,75,000
Full time
Yesterday
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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.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.