Company : Sain Medicaments Pvt Ltd, Uppal, Hyderabad, Telangana.
Position: Senior Executive – Regulatory Affairs
Industry: Pharmaceutical Formulations
Experience: 5–6 Years
Location: Hyderabad
Department: Regulatory Affairs
? Key Requirement: Hands-on experience in ROW / Emerging Markets
We are looking for an experienced Regulatory Affairs skilled with strong exposure to pharmaceutical formulations and regulatory submissions across Asia, Africa, LATAM, CIS, and Middle East markets.
? Key Responsibilities
• Manage end-to-end regulatory activities for ROW / Emerging Markets
• Prepare, compile, review and submit regulatory dossiers for pharmaceutical formulations
• Handle new product registrations, renewals, variations, re-registrations and post-approval changes
• Prepare and review dossiers in CTD / country-specific formats, as applicable
• Coordinate responses to regulatory queries, deficiencies and clarification requests
• Liaise with regulatory authorities, local agents, consultants and overseas business partners




• Review country-specific regulatory requirements and ensure dossier compliance
• Coordinate with QA, QC, R&D;, Production, Packaging, Supply Chain and Business Development teams for regulatory documentation
• Manage regulatory lifecycle activities and ensure timely submissions/approvals
• Track registration status, renewals, variations and regulatory commitments
• Monitor regulatory updates and provide regulatory intelligence for assigned markets
• Support business development and new market expansion by providing regulatory inputs and feasibility assessments
? Preferred Market Exposure
? Asia
? Africa
? LATAM – Latin America
? CIS Countries
?️ Middle East / GCC
? Candidate Profile
✔ 5–6 years of experience in Regulatory Affairs – Pharmaceutical Formulations
✔ Strong hands-on experience in ROW / Emerging Market registrations
✔ Good understanding of CTD and pharmaceutical regulatory documentation
✔ Experience in registrations, renewals, variations and

📌 Senior Regulatory Affairs Specialist (Uppal)
🏢 SAIN MEDICAMENTS
📍 Uppal