Roles & Responsibilities
• Prepare and review CTD and ACTD dossiers for OSD products
• Compile and maintain Process Validation (PV) documentation
• Prepare and review stability study documentation
• Develop Product Development Reports (PDR)
• Perform artwork checking and regulatory compliance review
• Prepare SmPC, package inserts, and leaflets
• Ensure AMV and CDP matching and regulatory accuracy
• Prepare and review specifications, COA, and MOA documents
• Handle finished product specifications and DMF documentation support
• Draft and submit product permissions, COPP, and FSC dossiers
• Independently prepare, review, and manage regulatory documentation
Qualification
• B.Pharm / M.Pharm / M.Sc (Pharmacy background preferred)
Experience
• 1–4 years of experience in Pharmaceutical Regulatory Affairs
• Hands-on exposure to OSD regulatory submissions
• Strong knowledge of CTD and ACTD formats
• Familiarity with Indian and export regulatory requirements
Skills
• Strong regulatory documentation and dossier compilation skills
• High attention to detail and compliance accuracy
• Good written and verbal communication skills
• Ability to work independently and manage multiple submissions
• Strong understanding of pharmaceutical lifecycle management
About the Organisation
Noronic Pharmaceutical Private Limited is a growing Indian pharmaceutical company focused on delivering high-quality pharmaceutical products across domestic and international markets. The organization offers a stable work environment, hands-on regulatory exposure, and long-term career growth opportunities for Regulatory Affairs professionals.
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