International Regulatory Affairs (IRA) - Executive

Roles & Responsibilities:
• Prepare, review, and submit regulatory dossiers for international markets as per country-specific requirements.
• Handle CTD/ACTD dossier compilation, variations, renewals, and lifecycle management activities.
• Coordinate with internal departments such as QA, QC, R&D, and Production for regulatory data.
• Respond to regulatory authority queries, deficiency letters, and follow-ups within timelines.
• Track regulatory guidelines and ensure compliance with international regulatory standards.
• Maintain and update regulatory documentation, databases, and product registration status.
• Support audits, inspections, and regulatory intelligence activities.

Qualification:
• B. Pharm / M. Pharm

Experience:
• 3 to 6 years of experience in International Regulatory Affairs
• Hands-on experience in export market registrations is preferred

Skills:
• Strong knowledge of international regulatory requirements and dossier submissions
• CTD/ACTD documentation and lifecycle management expertise
• Good coordination and communication skills
• Attention to detail and regulatory compliance mindset
• Ability to manage multiple submissions and deadlines

About the Organization:
BioMatrix Healthcare Private Limited, established in 2007 and headquartered in Ahmedabad, Gujarat, is a leading export-oriented pharmaceutical company engaged in the research, development, and manufacturing of oral solid dosages, liquids, and dry syrups, with global certifications including WHO-GMP, EU-GMP, and Health Canada, and a strong presence in over 30 international markets with more than 1000 product registrations worldwide.