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 Skills: Clinical Trials, Risk Assessment, Compliance Management, Regulatory Submissions, Quality Assurance, Project Management Experience: 6.00-7.00 Years