Avantika Medex Pvt. Ltd. is Hiring for Regulatory Affairs – Executive IRA

Avantika Medex Pvt. Ltd., a name committed to delivering excellence in pharmaceutical healthcare, is expanding its Regulatory Affairs team. We are currently looking for a skilled and experienced professional to join us in the role of Executive – IRA at our Head Office.

This opportunity is ideal for someone with a strong background in pharmaceutical regulatory operations, documentation, and international compliance. If you are passionate about advancing healthcare through meticulous regulatory practices, this position is for you.

Position Details:

• Designation: Executive – IRA

• Department: Regulatory Affairs

• Qualification: B.Pharm / M.Pharm

• Experience Required: 4–6 years

• Location: Head Office

Key Areas of Expertise Required:

1. Dossier Preparation in CTD, ACTD, and country-specific formats

2. Re-registration and Renewal of pharmaceutical products

3. Variation Applications and Regulatory Query Handling

4. DMF (Drug Master File) Activities

5. Artwork Review including carton, foil, labels, inserts, and shippers

6. Preparation of Pack Inserts as per specific country guidelines

7. Coordination with Internal Departments (F&D, QA, QC, Store) for document and sample collection

8. Document Review Skills:

   • Pharmaceutical Development Reports

   • Process Validation Protocols and Reports

   • Excipient and Finished Product Specifications (MOA)

   • COA, Stability Study Protocols

   • Manufacturing and Batch Records (MFR, BMR, BPR)

   • Literature Search Strategies (Clinical/Non-clinical)

   • AMV, CDP, and BE Study reports

Preferred Regional Experience:

• Uzbekistan

• Kazakhstan

• Azerbaijan

Dosage Forms Exposure:

• Tablets

• Capsules

• Sachets

• Ointments

• Injections

How to Apply:

Interested candidates may share their updated resume at:

📧 Email: hr@avantikamedex.com
📞 Contact Number: +91 96248 49118
🌐 Website: www.avantikamedex.com

📲 You can also scan the QR code available on our official job poster to apply directly.

At Avantika Medex, we believe in empowering professionals to contribute meaningfully to the healthcare ecosystem. Join us and be a part of a company that is “Committed towards good health…”