Uniza Group is a leading pharmaceutical company specializing in generic formulations, regulatory compliance, and global market expansions. With a strong presence in ROW (Rest of World) markets, we ensure high-quality drug submissions and approvals. Our team thrives on innovation, compliance, and excellence in regulatory affairs, dossier submissions, and legal documentation.
📌 Job Description: Regulatory Affairs Executive (ROW Markets)
Key Responsibilities:
✅ Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets.
✅ Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers.
✅ Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance.
✅ Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards.
✅ FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC).
✅ Legal Documentation: Track notarized & legalized documents for international submissions.
✅ Growth Opportunities: Take on additional responsibilities based on performance.
🎓 Eligibility & Requirements
- Education: B.Pharm / M.Pharm (Pharmacy graduates preferred).
- Experience: 1–4 years in regulatory affairs, dossier submissions, or pharma compliance.
- Skills:
- Strong knowledge of ACTD/CTD dossier formats.
- Familiarity with FDA, EMA, and ROW market regulations.
- Attention to detail in documentation & compliance checks.
- Proficient in regulatory tracking systems & MS Office.
💼 Employee Benefits
✔ Competitive salary & performance incentives.
✔ Career growth in global regulatory affairs.
✔ Work with a dynamic, compliance-driven team.
✔ Health benefits & professional development programs.
📩 How to Apply?
Ready to advance your career in pharma regulatory affairs?
📧 Email your resume to: hr_corporate@unizagroup.com
📍 Location: Ahmedabad, India
