Ganeshchandra Gopishetti

Qualified Senior REGULATORY OFFICER with 8 years of experience overseeing regulatory compliance as well as submission, tracking and approval of applications. Highly effective at aiding development of regulatory strategies, submitting applications and Reviewing. Successful at working collaboratively with cross-functional internal departments as well as external contacts.

• Participated in posture presentation on structure of human cell at Bidar Vidya Kendra.
• Participated in Orientation seminars.
• Participated in Orientation seminar on morphology and microscopy on senna leaf.

India

H.no-1-7-46/503,venkata Ramana Residency, Chaitanyapuri, Dilshuknagar, Hyderabad.

• Preparing and submitting ANDA dossiers according to Country specific guidelines for both Human and Veterinary medicinal products.
• Preparing and compilation of product dossiers in CTD & ACTD formats for Semi Regulated and ROW markets.
• Reviewing Product Dossiers, Reviewing technical documents like Analytical reports, Process Validation Reports, Process Validation Protocols, Master Formula Records, Batch Manufacturing Records, Pharmaceutical Development Reports, and Stability Data.
• Coordinating with R&D, QC & QA departments to obtain the technical information.
• Handled queries raised by various Regulatory Bodies
• Compilation of various Pharmacological, Pre-clinical, toxicological & Efficacy data based on Published Literature.
• Maintaining the product registration & Renewal status in different countries.
• Legalization of registration documents from respective Embassy
• Preparation and review of artwork as per country requirements.
• Preparing product technical sheets and technical Documents as per the Regulatory guidelines & Participating in tenders globally.
• Participating in presentation of the products to the customers globally.

• Ability to work effectively in a team.
• Ability to learn quickly and easily adaptable to environment.

• Date of Birth: 09/19/1989
• Gender: Male
• Marital Status: Married

I hereby declare that all the details furnished above are true to the best of my knowledge.