Regulatory Affairs Associate

Company Description

Eugia Pharma Specialities Ltd., a fully integrated subsidiary of Aurobindo Pharma, specializes in general injectables and oncology, offering a comprehensive portfolio across various therapeutic areas. The company operates globally, with facilities and teams in the USA, Europe, Brazil, Mexico, Canada, Colombia, ANZ, and other Emerging markets.

Role Description

This is a full-time on-site role for a Regulatory Affairs Associate, located in Hyderabad. The Regulatory Affairs Associate will be responsible for preparing and reviewing regulatory documentation, ensuring regulatory compliance, understanding regulatory requirements, and managing regulatory submissions across Emerging Markets. The position also involves coordinating with internal teams and regulatory bodies to ensure that all processes adhere to regulatory guidelines.

Qualifications

• Skills in preparing and reviewing Regulatory Documentation
• Knowledge of Regulatory Compliance and understanding of Regulatory Requirements
• 04 - 08 years of experience in preparation of dossiers for Regulatory Submissions in Emerging Markets (Asia, Africa, CIS, MENA, Brazil, South Africa markets)
• Excellent analytical and problem-solving abilities
• Strong written and verbal communication skills
• Master’s degree in Pharmacy.
• Ability to work collaboratively in a team and interact with regulatory bodies