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Prem Kumar Venkatesh

@premkumarvenkatesh

Regulatory Affairs Intern at Crown Medical Research and Pharmaceutical Science College of Canada, developing a 505(b)(1) NDA reconstruction.

United States

Message

At Crown Medical Research and Pharmaceutical Science College of Canada, I lead a team developing a 505(b)(1) NDA reconstruction across CTD Modules 1–5. I prepare technical summaries and submission content, and review documents for accuracy and cross-module consistency.

At Sigma Molecules LLC, I developed FDA/EMA CMC regulatory strategy for a manufacturing change and authored approved training modules on change classification, CTD narratives, comparability, and submission strategy. Earlier, at MEYER Organics Private Limited, I reviewed supplier records for cGMP compliance and updated SOPs and templates, contributing to a 20% reduction in review and clearance cycles.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Intern (Team Lead)

Current

Crown Medical Research and Pharmaceutical Science College of

Sep 2026 - Present (1 month)

Lead a team developing a 505(b)(1) NDA reconstruction, coordinating regulatory documentation, technical reviews, and submission-readiness activities across CTD Modules 1-5. Prepare Module 2 technical summaries and structure Module 3 documentation in accordance with ICH M4/M4Q requirements.

Regulatory Affairs 505(B)(1) NDA ECTD Modules ICH M4 eCTD Document Control Technical Review Version Control Labeling FDA Form 356h PLR

Regulatory Affairs Intern

Sigma Molecules LLC

Apr 2026 - Jul 2026 (3 months)

Analyzed FDA SUPAC and postapproval CMC guidances, incorporating PAT and Process Validation to develop recommendations supporting SUPAC modernization. Developed an FDA/EMA comparative CMC regulatory strategy for a manufacturing change, evaluating PAS versus Type II pathways.

FDA Regulations Surpac CMC PAT Process Validation Regulatory Strategy EMA FDA Filings PAS EU Type II Variations Comparability Protocols Regulatory Writing Training Modules ICH Q11

Regulatory Affairs Intern

MEYER Organics Private Limited

Jan 2023 - Apr 2023 (3 months)

Reviewed supplier documentation, Certificates of Analysis, and controlled records for cGMP compliance, supporting documentation accuracy and inspection readiness. Maintained document control and version accuracy while updating SOPs, contributing to a 20% reduction in review cycles.

GMP Document Control SOPs Certificate Of Analysis Labeling Regulatory Documentation Version Control Inspection Readiness