Avantika Medex Hiring for Regulatory Affairs – Executive Position

Explore an exciting career opportunity in Regulatory Affairs at Avantika Medex Pvt. Ltd. If you are a qualified B.Pharm or M.Pharm graduate with 4 to 6 years of hands-on experience in international regulatory submissions, this position at the Head Office (HO) could be your next big move.

Avantika Medex, committed to advancing healthcare through quality pharmaceutical products, is expanding its regulatory team. This role is an excellent opportunity to work on dossiers, re-registrations, variations, and regulatory communications across multiple global markets including Uzbekistan, Kazakhstan, and Azerbaijan.

Job Overview

Position Title: Executive – Regulatory Affairs

Department: Regulatory Affairs

Location: Avantika Medex Head Office

Qualification Required: B.Pharm / M.Pharm

Experience Required: 4–6 Years

Industry: Pharmaceuticals – Solid Dosage, Injectables, Topicals

Key Responsibilities

As a Regulatory Affairs Executive at Avantika Medex, you will:

• Prepare and compile dossiers in CTD, ACTD, and country-specific formats
• Handle re-registration, renewal, and variation applications across different regulatory authorities
• Coordinate responses to regulatory queries from global agencies
• Manage Drug Master File (DMF) activities and associated documentation
• Conduct detailed artwork reviews – including carton, foil, label, shipper, and inserts
• Create pack inserts following specific country guidelines
• Collect registration-related samples and documents from F&D, QA, QC, and Stores

Review technical documents such as:

• Pharmaceutical Development Reports
• Process Validation Protocols & Reports
• Specifications/MOA for excipients and packaging materials
• Stability protocols, MFRs, BMRs, BPRs
• Clinical and non-clinical literature review
• BE Study data and Analytical Method Validation (AMV)

Region-Specific Regulatory Experience

Candidates with exposure to regulatory submissions for the following countries will be preferred:

Uzbekistan

Kazakhstan

Azerbaijan

Dosage Forms You’ll Work With

Experience with the following dosage forms will be advantageous:

• Tablets
• Capsules
• Sachets
• Ointments
• Injections

📍 Job Location

Workplace: Avantika Medex Pvt. Ltd.

Location: Head Office

Contact Email: hr@avantikamedex.com

Phone Contact: +91 96248 49118

How to Apply

Qualified and interested candidates can send their CVs directly to hr@avantikamedex.com.