Global Regulatory Affairs Coordinator

7 days ago


Ahmedabad, Gujarat, India Medical Device Manufacturing Full time

A career opportunity exists for an experienced International Regulatory Affairs Executive to join our client's regulatory affairs team in the medical device manufacturing industry.

Company Overview

Our client is a leading manufacturer and exporter of urology, laparoscopy, gynecology, dialysis, cardiology, and gastrology products. They have established their presence in over 85 countries worldwide.

Job Summary

The International Regulatory Affairs Executive will play a crucial role in ensuring compliance with international regulatory guidelines, coordinating with internal teams, and liaising with regulatory authorities for approvals. Key responsibilities include dossier preparation and submission, regulatory compliance and documentation, coordination and communication, and regulatory intelligence and updates.

Responsibilities
  1. Dossier Preparation & Submission:
  • Compile, review, and submit regulatory dossiers as per country-specific requirements for ROW, Asian, and African markets.
  • Ensure timely preparation and submission of dossiers, including CTD, ACTD, and country-specific formats.
Regulatory Compliance & Documentation:
  • Maintain up-to-date knowledge of international regulatory guidelines (ICH, WHO, country-specific regulations).
  • Ensure compliance with regulatory requirements for product registration, renewals, and variations.
  • Prepare and review technical documents, including stability data, product formulation, and analytical reports.
Coordination & Communication:
  • Liaise with internal departments such as R&D, Quality Assurance, Quality Control, and Production to collect required documents.
  • Communicate with regulatory authorities and clients to address queries and ensure smooth approval processes.
Regulatory Intelligence & Updates:
  • Monitor and update changes in regulatory guidelines for ROW, Asian, and African markets.
  • Implement necessary updates in documentation and processes to align with regulatory changes.
Requirements
  • 1 or 2 years of experience in Regulatory Affairs for ROW, Asian, and African markets.
  • Prior experience in dossier preparation and submissions.
  • Strong understanding of regulatory guidelines and dossier requirements.
  • Detail-oriented with strong documentation and organizational abilities.
  • Proficiency in MS Office (Word, Excel, PowerPoint).

Contact Person: Neha Sharma



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