Regulatory Affiars - Asst. Manager

Roles & Responsibilities
• Manage designated regulatory projects and ensure timely completion as per agreed deadlines
• Author, review, and compile CMC documentation for EU MAA submissions and post-approval variations
• Handle regulatory submissions for EU and LATAM markets using eCTD publishing tools
• Coordinate regularly with internal stakeholders to source and compile required documents within project timelines
• Review regulatory dossiers against current agency guidelines to ensure full compliance
• Maintain up-to-date knowledge of EU and LATAM regulatory requirements and evolving guidelines
• Manage regulatory documentation lifecycle including filing, archiving, tracking, and database maintenance
• Ensure traceability and proper maintenance of regulatory history for all assigned products

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

Experience
• 8+ years of hands-on experience in Regulatory Affairs
• Strong exposure to EU and LATAM regulatory markets
• Proven experience with CMC documentation and eCTD submissions

Skills
• In-depth knowledge of EU MAA and post-approval regulatory processes
• Strong documentation, review, and compliance skills
• Good coordination and stakeholder management abilities
• Familiarity with regulatory databases and eCTD publishing software
• Strong attention to detail and ability to manage multiple projects simultaneously

About the Organization
Centaur Laboratories Pvt. Ltd. is a leading Indian pharmaceutical company with a strong presence in domestic and international markets. The organization is known for its quality-driven approach, regulatory excellence, and commitment to delivering compliant, high-quality pharmaceutical products across global markets.