Regulatory Affairs Officer (Plant RA)

Roles & Responsibilities
• Preparation and compilation of regulatory dossiers in CTD & ACTD formats
• Handling regulatory documentation for EU, UK, Australia, and Ukraine markets
• Ensuring compliance with ICH guidelines and international regulatory requirements
• Managing regulatory submissions and lifecycle management activities
• Overseeing plant-level regulatory documentation and compliance
• Coordinating with QA, QC, and Production teams for regulatory alignment
• Maintaining document management systems and regulatory records
• Supporting audit readiness and regulatory inspections
• Ensuring timely response to regulatory queries and deficiency letters

Qualification
• B.Pharm (Bachelor of Pharmacy) Mandatory
• M.Pharm (Master of Pharmacy) Preferred

Experience
• 1–4 years of experience in Regulatory Affairs (Plant RA)
• Mandatory experience in pharmaceutical formulation
• Experience in handling EU and UK regulatory markets preferred

Skills
• Strong knowledge of CTD & ACTD dossier preparation
• Expertise in ICH Guidelines and international regulatory standards
• Regulatory documentation and submission management
• Plant Regulatory Affairs coordination
• Regulatory compliance management
• Excellent communication and documentation skills
• Attention to detail and strong organizational ability

About the Organization
Icpa Health Products Ltd is a reputed Indian pharmaceutical company specializing in formulations with a strong presence in domestic and international markets, committed to quality manufacturing and global regulatory compliance.