shubham ghuge

Entry-level Regulatory Affairs

Pune, Maharashtra, India

Profile Score

About

Bachelor of Pharmacy graduate with strong knowledge of Regulatory Affairs, CTD/eCTD dossier preparation, ICH guidelines (Q1–Q10), USFDA, EMA, and CDSCO regulations. Experienced in GMP documentation, stability data review, regulatory compliance, and scientific research documentation. Published research author with proven analytical skills, attention to detail, and strong understanding of pharmaceutical lifecycle management. Seeking an entry-level Regulatory Affairs role.

Skills & Expertise (44)

Selenium WebDriver Intermediate

7.6/10

Years Exp

Automation Testing Intermediate

7.6/10

Years Exp

Jira Intermediate

7.5/10

Years Exp

SQL Intermediate

7.2/10

Years Exp

Java Intermediate

7.2/10

Years Exp

HTML Postman Maven Git Agile-Scrum Waterfall Jenkins Oracle TestNG XML Windows Manual Testing Core Java OOPs Concepts Cucumber Appium POM Apache POI Firebug Accuracy Data review Document Management Systems MS Office Word Excel PowerPoint Documentation Skills Analytical Thinking Attention to Detail Rest-Assured Problem-solving ability Effective Communication Team Collaboration Time management Organizational Skills Adaptability Eclipse Change Control Hybrid Framework

Work Experience

Industrial Trainee

Kilitch Drugs (India) Pvt. Ltd.

Present - Present

Exposure to pharmaceutical manufacturing, QA, and QC operations. Assisted in GMP documentation review and compliance monitoring. Observed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). Understood regulatory compliance requirements as per USFDA and CDSCO. Supported documentation control and SOP review processes.