Profile Details

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USD 8 /hr

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Hire Kartik B.

India

USD 8 /hr

Regulatory Affairs Specialist | US FDA Submissions | Pharma Documentation

Profile Summary

Detail-oriented and motivated Regulatory Affairs professional currently working at an Indian MNC, focusing on regulatory submissions for US markets. I bring hands-on experience in compiling and reviewing ANDA dossiers, preparing responses to FDA queries (CRLs, IRs, DRLs,) and managing post-approval changes related to CMC and Labeling such as CBE-0, CBE-30 and Annual Reports. I also support end-to-end labeling activities, including SPL creation, artwork review, and submission via FDA ESG NextGen portal. Skilled in eCTD compilation and lifecycle management, I work closely with cross-functional teams to ensure compliance, accuracy , and timely regulatory filings. Keen to grow further in global regulatory strategy, CMC, Labeling and dossier management, while contributing to high-quality, complaint drug product submissions that improve patient access.

Subject Matter Expertise

• ☆ Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Regulatory Writing
• ☆ CMC Documentation

Services

• Consulting

Consulting Healthcare Consulting

Work Experience

Jamia Hamdard

- Present

Regulatory Affairs Specialist

Jubilant Generics Limited

August 2024 - Present

Education

Masters of Pharmacy

Jamia Hamdard

July 2022 - June 2024

Certifications

• Advanced Diploma in Drug Regulatory Affairs

  Jamia Hamdard

  January 2024 - Present