Department :IRA
Position:Head or Manager
Experience :Minimum 15+ years or above
Location :Ahmedabad

Job Description :
• Global Regulatory Submissions – CTD / ACTD / Dossier Compilation
• Product Registration & Lifecycle Management
• Variation Filing & Regulatory Strategy
• Regulatory Query Management
• Bioequivalence & Clinical Documentation Support
• Drug Master File (DMF) Review
• Pharmacovigilance Documentation (PSMF / PSUR / RMP)
• Artwork & Labeling Compliance
• GMP Regulatory Compliance
• Regulatory Agency Coordination
• Contract Manufacturing Regulatory Support
• Third-Party Manufacturing Site Audit & Regulatory Compliance
• Team Leadership & Training

MARKET EXPERIENCE:

CIS Countries

Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan, Georgia, Azerbaijan

ASEAN Countries

Philippines, Vietnam, Thailand, Malaysia, Cambodia, Indonesia, Myanmar

African Countries

Ethiopia, Ghana, Nigeria, Burkina Faso, Ivory Coast, Togo, Mali, Mauritania