Pavan Kumar Boorlu

Highly motivated employee with desire to take new challenges. Strong work ethic, adaptability and good interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Working since August 2017 to till date as a regulatory professional. Total 6.4 years of experience in DMF, ANDA, IND and NDA (s) pre and post approval filings. Completed bachelor’s in pharmacy during the academic year September 2012 to May 2016.

• Father's Name: B. Srinivasa Rao
• Mother's Name: B. Laxmi
• Date of Birth: 08/20/95
• Nationality: Indian

• Innovative
• Passionate
• Hardworking
• Goal oriented
• Preferential optimistic attitude with dynamic in nature
• Ability to work for long hours
• I can mould easily to the situations

Telugu, English, Hindi (can manage)

• CoPP ordering, handling Lorenz, and Pharmaready
• Compiling the Sections in eCTD Publishing Software’s (Lorenz Pharmaready, TRS Publisher)
• Sound knowledge in internal and external linking.
• Having Decent experience in working in client environment
• Having good experience in working with the entire cross functional teams i.e., R&D, QC, and QA for collecting all the technical documents
• Review of change controls, specifications, test procedure and stability protocols and other technical documents
• Accessing the technical changes and concluding how to notify the major and minor changes to regulatory bodies
• Sound Knowledge on original DMF submissions to US, Canada, and ROW countries
• Sound knowledge on submitting the Quality and Administrative amendments
• Preparation of annual reports to USFDA
• Preparation of open part and restricted part(s) for ROW countries

• Nano Suspensions, A novel approach on drug delivery system at Raghu College of pharmacy and at Bhaskara Institute of Pharmacy
• Presentation on green chemistry at Bhaskara institute of pharmacy

• Review of Ad-Promo Submissions and Submitting to USFDA
• Review of Safety Report Submission and submitting to USFDA
• Review of CMC Documents (DMF, ANDA) as document level processor
• Submitting the Regulatory submissions through ESG (Electronic Gateway Submissions)
• Preparation and compilation of DMF sections to regulatory submissions for US, Canada, and other ROW (Rest of World) countries
• Review of Technical documents such as Specifications, Test procedures, Method validation reports, Process development report, stability protocols, SOP(s) and other technical documents
• Preparation of Module-1 to 3 sections for eCTD and Ness submissions
• Preparation of annual reports to USFDA
• Preparation of sections for quality amendments (pre and post approval products) for US, Canada
• Hand full of experience in eCTD Software (Parma Ready and Lorenz), TRS- Publisher, in publishing part i.e. document uploading, internal and external hyperlinks and bookmarks in the sections
• Preparation of open part and closed part DMF to ROW countries
• Gap analysis of source/supporting documents in line with country specific requirements for USFDA, CHINA, CANADA and ROW Countries
• Handling of deficiency responses for ROW Countries
• Communicate with clients for project-based doubts
• Maintenance of database / track wise entries
• Responsible for Project Management activities
• Involved in the Product Portfolio preparation activities during development to Execution of Products

Playing cricket, reading books and listening to music and e-Learning

Development and validation of analytical method for the estimation of “DASATANIB” and “LEVOFLOXACIN” in bulk and formulation by U.V visible Spectrophotometry

I hereby affirm that the information provided above is true and correctly described to the best of my knowledge.

• Playing cricket
• Reading Books
• Listening Music

• Collaboration Award in DxC during 2021 Quarterly awards.
• Appointed as Quality Check Champion within very short period of time in DxC and in Sandoz.
• Appointed as Trainer to new joiners.