Executive - DRA (Drug Regulatory Affairs)

Roles & Responsibilities
• Preparation, compilation, and submission of DMFs as per regulatory requirements
• Handle regulatory queries and coordinate with internal departments for timely responses
• Support dossier preparation for domestic and international markets
• Ensure compliance with regulatory guidelines for exports
• Maintain regulatory documentation and track submission timelines
• Coordinate with QA, QC, and Production teams for required technical data
• Stay updated with global regulatory requirements and guidelines

Qualification
• M.Sc/ B.Pharm / M.Pharm

Experience
• 3–8 years of experience in Drug Regulatory Affairs
• Hands-on experience in DMF preparation and query handling
• Exposure to export documentation and international regulatory submissions

Skills
• Strong knowledge of regulatory guidelines and documentation
• Experience in DMF compilation and submission process
• Good communication and coordination skills
• Strong documentation and attention to detail
• Ability to manage multiple submissions and timelines
• Problem-solving and analytical skills

About the Organization
Synthimed Labs Private Limited is a pharmaceutical manufacturing company specializing in API development and production, with a strong focus on regulatory compliance, quality systems, and global market presence across multiple regulated and semi-regulated markets.