Susilkumar Subramaniyan

Regulatory Affairs professional with 5.7+ years of experience in pharmaceutical regulatory submissions and publishing. Hands-on expertise in eCTD, NeeS, Paper submissions, end-to-end publishing, lifecycle management, M1 document preparation, ESG Gateway submissions, validation, and regulatory archiving. Experienced across US, EU, Canada, Australia, and ROW markets, with exposure to NDA, ANDA, IND, ASMF, CSR, and AdPromo/Promotional Labeling submissions.

Junior Regulatory Associate at NAVITAS LIFE SCIENCES PVT. LTD. (2021-02 – Present)

• Manage end-to-end regulatory publishing activities for pharmaceutical submissions across global markets.
• Prepare, compile, publish, validate, and quality-check regulatory submission sequences in accordance with applicable requirements.
• Handle eCTD, NeeS, and Paper submissions for US, EU, Canada, Australia, and ROW markets.
• Support NDA, ANDA, IND, ASMF, CSR, and AdPromo/Promotional Labeling submissions.
• Prepare and manage Module 1 (M1) documents, ensuring appropriate placement, metadata, leaf titles, bookmarks, and hyperlinks.
• Perform submission-level quality checks and eCTD validation; identify and resolve validation issues using Lorenz eValidator.
• Support ESG Gateway submission and transmission activities to regulatory agencies.
• Manage regulatory lifecycle activities, including subsequent sequences and submission updates.
• Coordinate with cross-functional teams to obtain required documents, resolve publishing queries, and meet submission timelines.
• Perform regulatory submission archiving and maintain submission-related documentation.
• Handle electronic and paper-based submission requirements while maintaining quality, accuracy, and compliance.

Master of Pharmacy (M.Pharm) in Regulatory Affairs