- 10-12 years of experience in DRA.
- Liaise with officials of FDA, CDSCO/DCGI.
- Prepare strategy to ensure timely and smooth movement and approval of applications for COPP, Additional product permissions, GMP, Test License, MMC & subsequent New drugs and all other work related to Drug Licensing Authorities.
- Prepare and review technical documents, dossiers in format of CTD/ACTD.
- Check compliance status of the Quality Systems.
- Evaluate and comment about requirement of Clinical studies.
- Prepare artworks of packaging materials as per current rules and regulations.
- Must have worked on ROW market, dossier filling.
- Exposure to EU-GMP, USFDA & MHRA audits.
- Exposure to DRA
- Fine analytical skills with a sprit to work as a team
- Coordinating with various sections of production
- Willing to travel
- Excellent communication skills
CTC-Best in industry