Regulatory Affairs Manager

Company Description

Zenith Drugs Limited, with over two decades of service, is a leading pharmaceutical manufacturing unit recognized by healthcare practitioners and government institutions. The company holds a WHO-GMP certification and specializes in diverse pharmaceutical products, including oral rehydration salts (ORS), where it is one of the largest manufacturers in central India. Zenith has strong domestic market presence through its subsidiaries, Biozen Healthcare and Biogenesis Corporation, and supplies products to prominent clients like Ajanta Pharma and Micro Labs. With a growing international footprint, the company exports to over 15 countries and ensures compliance with WHO-GMP and ICH guidelines in its manufacturing and documentation. Zenith employs cutting-edge technology to deliver high-quality medicines globally.

Role Description

This is a full-time on-site role for a Regulatory Affairs Manager at Zenith Drugs Limited located in Kota. The Regulatory Affairs Manager will oversee the preparation, coordination, and submission of regulatory documentation to comply with international requirements. Daily responsibilities include ensuring adherence to regulatory compliance standards, managing regulatory activities, and coordinating with internal teams to maintain quality systems. The role involves staying informed on updates to regulatory requirements and ensuring that company products meet all necessary standards and guidelines.

Qualifications

• Proficient knowledge and experience in Regulatory Compliance and understanding of Regulatory Requirements
• Expertise in Regulatory Affairs and managing Regulatory Submissions
• Strong understanding and implementation of Quality Systems
• Strong analytical, organizational, and communication skills
• Familiarity with WHO-GMP and ICH Guidelines
• Bachelor’s or Master’s degree in Pharmacy or a related field
• Experience with CTD/ACTD/e-CTD dossier preparation and submission is a plus