Praveen Karamcheti

A pharmaceutical Post-graduate with over 9 years experience in pharmaceutical sector in UK and India. Worked in QA and Regulatory department of reputed global pharmaceutical companies having MHRA and FDA accreditation. I am positive, self-motivated, adaptable, able to learn things quickly and always keen on learning new things. Had good knowledge on key aspects of quality, regulatory, GMP, ICH, FDA, Health Canada and EMA guidelines. A good team player with ability to work effectively under tight deadlines.

• To timely author high quality global drug product CMC documentation to support regulatory submissions in EU, ROW, US and Canada according to current regulatory guidelines and e-publishing requirements.
• Identify the required documentation and any quality and/or timelines issues for global post approval submissions (Renewals, site transfers, other variations) and negotiate the delivery of approved technical source documents with manufacturing sites, ESO, LCM and regulatory publishing teams in accordance with project timelines.
• To ensure timely provision of all the required regulatory documentation to CPOs for post approval submissions in EU, ROW, Canada and US. This includes CTD modules 1-5 and ancilliary documents.
• To draft and submit timely responses to Health Authorities queries globally.
• To author WHO QOS and QIS to support regulatory submissions in French west African countries
• To contribute in global regulatory strategies for post approval submissions
• To perform compliance checks and ensure regulatory compliance of the global CMC dossier.
• To liaise with regulatory publishing team and ensure dossier is published in desired format.
• Review of all the source documentation to ensure regulatory compliance and data integrity.
• To perform QC review of CMC dossier prior to dossier dispatch to CPOs
• To perform operational activities in support of the project such as data entry into the regulatory documentation management system, CMC databases and other operational activities as needed                                                          
• Ensure excellence in planning and timely delivery of critical regulatory materials such as registration samples and certificates such as CPPs, GMPs, TSE etc. in order to support renewal and production transfer submissions in ROW countries.

Masters in Pharmaceutical Analysis-Kingston University, United Kingdon, London

Bachelor of Pharmacy- Andhra University, India