Barshaik Mohammed Sami

About Barshaik Mohammed Sami

Pharmacy graduate with strong hands-on experience in Quality Control (QC) and a growing specialization in Regulatory Affairs (RA) and Clinical Data Management (CDM). I bring practical exposure to cGMP, GDP, ICH guidelines, stability studies, analytical documentation, and data integrity (ALCOA+), along with a proven ability to manage compliant workflows in fast-paced pharmaceutical environments.While working in QC, I developed a keen interest in the regulatory and data side of the drug development lifecycle—particularly in regulatory submissions, dossier preparation, compliance review, clinical data workflows, and documentation accuracy. I am now actively transitioning into RA and CDM roles where my analytical mindset, structured documentation skills, and guideline-driven approach can add stronger value.I am skilled in:• Regulatory documentation support• ICH, WHO, FDA, EMA guideline interpretation• QC documentation, deviation handling, SOP writing• Data integrity, audit readiness, compliance checks• LIMS, Oracle ERP, MS Office• Clinical data accuracy and process coordinationI am seeking opportunities where I can contribute to regulatory submissions, labeling compliance, lifecycle management, pharmacovigilance documentation, or clinical data review and coordination while continuing to grow as a regulatory and data professional. I bring precision, discipline, adaptability, and a strong commitment to compliance and data quality.Open to Regulatory Affairs, Regulatory Operations, Clinical Data Management, Drug Safety Documentation, and Quality/Regulatory Support roles.

Experience

1. Executive

   CuraTeQ Biologics

   Dec 2025 — Present · Hyderabad, IN

Education

• Jawaharlal Nehru Technological University Anantapur (JNTUA)

  Bachelor of Pharmacy - BPharm, Pharmacy

• Narayana junior college tirupati

  Intermediate, Science

• Jain english medium school kadiri

  SSC