Manager / Sr. Manager - Pharma - Regulatory Affairs ROW Market Andheri

Key Responsibilities

• Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for ROW markets
• Understand, interpret, and implement regulatory guidelines applicable to different ROW countries
• Prepare and renew registrations, manufacturing licenses, product permissions, WHO-GMP certificates, MSO registrations, and other required regulatory documentation
• Lead the preparation, review, and submission of regulatory documents to relevant health authorities across ROW markets
• Submit required information, responses, clarifications, and variations to regulatory authorities within defined timelines
• Obtain market-specific approvals such as product permissions, test licenses, plant approvals, free sale certificates, COPPs, and other necessary clearances
• Review product artworks to ensure compliance with regulatory requirements, country-specific labeling norms, and pharmacopoeial standards
• Ensure ongoing regulatory compliance and stay updated with changing regulations in ROW markets

Preferred Candidate Profile

• B.Pharm or M.Pharm graduate
• 7–8 years of experience in Regulatory Affairs for pharmaceutical formulations, specifically handling ROW markets
• Strong experience in preparation, review, and lifecycle management of CTD/ACTD dossiers for registration and renewal in ROW regions
• Experience in preparing and submitting applications to overseas regulatory authorities and coordinating with local agents, distributors, or manufacturers
• Strong knowledge of regulatory compliance, labeling requirements, and pharmacopoeial standards for ROW markets
• Excellent communication, coordination, and stakeholder management skills