Walk-In Interview for Regulatory Affairs at Avantika Medex

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Walk-In Interview for Regulatory Affairs at Avantika Medex

Are you looking for a rewarding career in Regulatory Affairs? Avantika Medex, a company committed to good health, is conducting a Walk-In Interview for the position of Senior Officer – Regulatory Affairs. If you meet the qualifications and have the required experience, this is your chance to join a dynamic team and contribute to our mission of delivering excellence in healthcare.

Position Details

Designation:

Senior Officer – Regulatory Affairs

Department:

Regulatory Affairs

Qualification:

  • B.Pharm/M.Pharm

Experience Required:

  • 3–4 years of relevant experience

Key Job Responsibilities

  1. Dossier Preparation:
    • Preparation in CTD/ACTD and Country-Specific Formats
  2. Re-registration and Renewal Applications
  3. Variation Applications
  4. Query Handling
  5. DMF Activities (Drug Master File)
  6. Artwork Review:
    • Carton, foil, label, insert, and shipper design reviews
  7. Pack Insert Preparation:
    • Ensure compliance with country-specific guidelines
  8. Documents and Sample Collection:
    • Coordination with F&D, QA, QC, and Store departments for registration requirements
  9. Document Review Knowledge:
    • Reviewing Pharmaceutical Development Reports, Process Validation Protocols, and Reports
    • Excipients Specifications/MOA, Finished Product Specifications/MOA, Packing Material Specifications/MOA
    • Certificates of Analysis (COA), Stability Study Protocols, MFR, BMR, BPR, AMV, CDP, BE Study, Clinical/Non-Clinical Literature Searches

Experience with Specific Countries

  • Kazakhstan, Azerbaijan, Turkmenistan
  • Philippines, Vietnam, Myanmar

Dosage Form Experience Required

  • Tablets
  • Capsules
  • Oral Powder (Sachet)
  • External Preparations (Gel & Cream)
  • Injections and Infusions

Walk-In Interview Details

  • Date: 9th January 2025
  • Time: 11:30 AM to 3:00 PM

Interview Venue

Avantika Medex
1308, Shapath V, Near Crown Plaza Hotel,
S.G. Highway, Vejalpur, Ahmedabad – 380051, Gujarat, India.

Additional Information

How to Apply:

  • Interested candidates can share their resumes at [email protected].
  • You can also scan the QR code provided in the official announcement to apply.

Contact for Queries:
Phone: +91 96248 49118
Website: www.avantikamedex.com

Walk-In Interview for Regulatory Affairs

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