Executive Regulatory Affairs

Roles & Responsibilities
• End-to-end dossier compilation from start to finish
• Strong working knowledge of CTD Modules 1, 2, 3, 4
• Conduct literature searches to support drug product development
• Day-to-day coordination with manufacturing, QA, QC, R&D, and external clients/agents
• Understanding of global regulatory pathways (EU, Brazil, Australia, South America)
• Compilation and submission of eCTD dossiers
• Regulatory database management and product lifecycle management
• Review of commercial and regulatory documents
• Identification of variation categories for post-approval changes
• Timely compilation, review, and submission of variations

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

Experience
• 3–5 years of relevant Regulatory Affairs experience
• Hands-on exposure to EU, Brazil, Australia, and South American markets

Skills
• Strong knowledge of eCTD, CTD modules, post-approval variations, and lifecycle management
• Excellent coordination and communication skills

About the Organization
CORONA Remedies Ltd. is a reputed Indian pharmaceutical company known for its commitment to quality, innovation, and global regulatory compliance. The company offers a collaborative work environment with opportunities to handle international regulatory submissions and complete product lifecycle management.