Regulatory Affairs Executive

Company Description

Micro Orgo Chem is a rapidly growing manufacturer of Active Pharmaceutical Ingredients (API), trusted by overseas and Indian customers for its quality and reliability. Managed by a team of young professional directors with expertise in finance and manufacturing, the company operates a fully integrated production facility adhering strictly to GMP regulations. With a focus on quality and consistency, it employs experienced QA managers to oversee every stage of production and supplier processes. Micro Orgo Chem has successfully expanded into a diverse range of pharmaceutical and specialty products, earning a strong reputation for timely delivery and customer satisfaction. The company is dedicated to maintaining excellence in quality, pricing, and on-time delivery to meet customer expectations.

Role Description

This is a full-time on-site position located in Vapi for a Regulatory Affairs Executive. The role includes preparing regulatory documentation, ensuring compliance with regulatory requirements, managing the preparation of dossiers, and supporting ongoing regulatory affairs to meet industry standards and company objectives. The successful candidate will collaborate closely with teams to ensure products align with all regulations and guidelines.

Qualifications

• Proficiency in Regulatory Documentation and understanding of Regulatory Requirements
• Experience in ensuring Regulatory Compliance and managing Dossier Preparation
• Knowledge and expertise in Regulatory Affairs processes
• Strong attention to detail, organizational, and communication skills
• Bachelor's or advanced degree in Pharmacy, Chemistry, or a related field
• Ability to work effectively in a fast-paced, on-site environment