Deepak Chaudhari

Pharma postgraduate with experience in Regulatory Affairs, including Dossier documentation, data compilation, segregation, labelling and artwork correction and the preparation of clinical and toxicological report summaries. I have experience in export sample arrangements and maintaining records. Additionally, I handle export documentation such as EDI and PFI.

I coordinate with clients and plants. I also have experience in clinical coding, where I review and analyze patient medical records to assign appropriate ICD-10 and CPT codes. Proficient in Power BI, SQL, and Excel, with proficiency in creating interactive dashboards, performing data analysis, and transforming datasets to support data-driven decision-making

Regulatory Affairs Officer - Lokbeta Pharmaceuticals - Mumbai, INDIA

(2019-10 - 2020-04)

• Dossier compilation Module 1 to 5 preparation.
• Labelling and artwork correction
• Gather and analyzed scientific data to formulate explanations and substitute reason for regulatory authority.
• Analyzed data from clinical studies for data preparation.

Regulatory Affairs Officer - Aishwarya Healthcare - Mumbai, INDIA

(2017-03 - 2019-09)

• Dossier Preparation -CTD, ACTD, Country specific format.
• Preparation of the Clinical & Toxicological report summary.
• Labelling and artwork correction.
• Sample arrangements and maintaining the records.
• Co-ordinate with plants and clients.
• Evaluation of changes to documents submitted to determine need for amendments.
• Provide the regulatory guidance to the organization on applicable regulations.
• Maintain the documents and records of approved documents for registered products.

Medical Coder - Gebbs Healthcare Solutions - Navi Mumbai, INDIA

(2015-10 - 2017-03)

• Review and analyze patient medical records data to assign appropriate ICD-10, CPT Codes.
• Review the documents to ensure completeness, accuracy, and compliance of medical records with coding guidelines and regulations.
• Stay updated with changes in coding standards, healthcare regulations, and industry best practices through ongoing education and training.
• Maintain patient confidentiality and adhere to HIPAA regulations while managing medical records and coding information.

M. Pharmacy - QA - North Maharashtra University, Jalgaon

B. Pharmacy - North Maharashtra University, Jalgaon

H.S.C - Maharashtra, Nasik Board

S.S.C - Maharashtra, Nasik Board