Deepak Kumar

About Deepak Kumar

Career Goal Seeking an opportunity in a reputed pharmaceutical or Pharma IT…

Experience

1. Sr Executive

   Rhydburg

   May 2024 — Present · Dehradun, IN

   Dossier Preparation & Review: Compile, review, and format CTD/eCTD/ACTD dossiers for submissions in ROW, US, CIS, and LATAM markets (e.g, Guatemala, Bolivia). Ensure CMC modules comply with ICH guidelines.Regulatory Submissions Management: Oversee end-to-end submissions, including new registrations, variations, renewals, and amendments for (LATAM), WHO, and local authorities in ASEAN, Africa, and Latin America.Query Response & Resolution: Address deficiency letters, clarification requests, and post-approval variations swiftly, ensuring compliance and minimal turnaround time.Market-Specific Regulatory Expertise: Apply in-depth knowledge of ROW and emerging market regulations (Latin America, ASEAN, Africa, CIS) to tailor dossiers for efficient approvals.Labelling & Artwork Compliance: Review package inserts, labels, and artworks to ensure compliance with regional guidelines, reducing non-compliance risks.Regulatory Intelligence & Gap Analysis: Monitor ICH, WHO, FDA/EMA, and regional guideline updates. Conduct gap analyses on legacy dossiers for lifecycle compliance.Technical Documentation: Prepare/review CMC documentation, including specifications, analytical methods, validation protocols, stability data, and bioequivalence studies. Support analytical method development/validation.Cross-Functional Collaboration: Coordinate with QA, QC, R&D, and production teams for submission data. Contribute to regulatory strategy planning with cross-functional inputs.Audit & Inspection Support: Assist in internal/external audits (WHO, local authorities), ensuring GMP/GLP/GDP compliance and addressing deviations.Lifecycle Management: Manage post-approval variations, renewals, and lifecycle updates to maintain market presence and compliance.Digital & AI-Driven RA: Utilize AI tools (e.g, ZOHO, ChatGPT for RA) for document review, it enhance efficiency.Additional Duties: Mentor junior RA team, support and participate in regulatory risk assessments for new launches.

Education

• Dr. Harisingh Gour University (Sagar University)

  Master’s Degree

  2014 — 2016

• Chhatrapati Shahu Ji Maharaj University

  Bachelor’s Degree

  2009 — 2013

Skills

• Microsoft Office
• Microsoft Excel
• Project Management
• Microsoft Word
• Powerpoint
• Strategic Planning
• Hplc
• Uv/Vis
• Ftir
• Drug Discovery
• Medicinal Chemistry
• Dissolution Testing
• Analytical R&D
• Synthetic Organic Chemistry
• High-Performance Liquid Chromatography (Hplc)
• Standard Operating Procedure (Sop)
• Gmp
• Good Laboratory Practice (Glp)
• Gas Chromatography
• Analytical Quality Assurance(Aqa)
• U.s. Title 21 Cfr Part 11 Regulation
• Regulatory Affairs