International RA Executive Job Opening

International RA Executive | Ahmedabad, Gujarat

About the Company

Our client is India’s largest and leading manufacturer and exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and Gastrology products. With a presence in over 85 countries, they are committed to delivering high-quality medical solutions globally.

Job Title: International RA Executive

Job Location: Ahmedabad, Gujarat, India

Job Description

We are hiring an International Regulatory Affairs (RA) Executive to join our client’s regulatory team. This role involves preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets while ensuring strict compliance with international regulations.

Key Responsibilities

Dossier Preparation & Submission

• Prepare, review, and submit regulatory dossiers as per country-specific guidelines for ROW, Asian, and African markets.
• Ensure timely preparation and submission of CTD, ACTD, and other country-specific formats.

Regulatory Compliance & Documentation

• Stay updated with ICH, WHO, and other regulatory guidelines.
• Ensure all documentation meets compliance standards for product registration, renewals, and variations.
• Review and maintain stability data, product formulation, and analytical reports.

Coordination & Communication

• Collaborate with R&D, Quality Assurance, Quality Control, and Production teams for required documentation.
• Address regulatory queries by communicating with authorities and clients.

Regulatory Intelligence & Updates

• Monitor and implement changes in regulatory guidelines for ROW, Asian, and African markets.
• Update documentation and processes accordingly.

Required Qualifications & Experience

• Education: B. Pharm, M. Pharm, MSc (Life Sciences, Chemistry, Biotechnology, or related fields)
• Experience: 1-2 years in Regulatory Affairs focusing on ROW, Asian, or African markets.
• Technical Skills: Knowledge of dossier preparation, submission guidelines, and regulatory documentation.
• Software Skills: Proficiency in MS Office (Word, Excel, PowerPoint).
• Other Skills: Detail-oriented, strong documentation and organizational abilities.

How to Apply

Interested candidates can send their resumes to: 📩 Neha Sharma (Hiring Contact) ✉️ unitedmkt1@uhr.co.in

🔗 Apply here: LinkedIn Job Post

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