• Managing regulatory affairs of the organization & its subsidiaries / associates.
• Liaising with regulatory bodies like State and Central FDA, DCI, etc.
• Well conversant with Drug law/feed supplement regulation.
• Co-ordination with factory, purchase department, marketing department.
• Reviewing of technical documents like process validation, stability, etc.
• Compilation of dossiers and handling dossier related queries.
• Arranging and checking artworks for registration as per guidelines.
• Compilation and preparation of tender documents.
• Preparation of Drug Material File