Sr.Officer/ Executive

Roles & Responsibilities
• Author and compile CMC documentation for ANDA submissions and post-approval variations for the US market
• Coordinate regularly with cross-functional stakeholders to source required documents within defined timelines
• Review regulatory documents in line with FDA guidelines to ensure compliance and submission readiness
• Support preparation, publishing, and lifecycle management of eCTD submissions
• Maintain up-to-date knowledge of US FDA regulatory requirements, guidance documents, and industry best practices

Qualification
• M.Pharm / B.Pharm / M.Sc

Experience
• 4–6 years of experience in Regulatory Affairs
• Strong exposure to US regulatory submissions (ANDA and post-approval)

Skills
• Hands-on experience in CMC documentation for US FDA submissions
• Working knowledge of eCTD publishing tools
• Good understanding of FDA regulations and guidance documents
• Strong coordination and documentation skills
• Ability to manage multiple submissions and timelines effectively

About the Organization
Centaur Laboratories Pvt. Ltd. is a reputed Indian pharmaceutical company with a growing global footprint. The organization is recognized for its regulatory excellence, strong compliance culture, and commitment to delivering high-quality, affordable medicines across international markets.