SOURAV KUMAR

Highly motivated and detail-oriented M.Pharma graduate in Regulatory Affairs with a strong academic record and a comprehensive understanding of global regulatory guidelines (e.g., ICH, FDA, EMA). Possessing a solid foundation in drug development processes, quality assurance, and dossier compilation (CTD/eCTD). Eager to apply theoretical knowledge and analytical skills to contribute to the successful navigation of regulatory pathways and ensure product compliance within the pharmaceutical industry.

• Analyzed complex data related to therapeutic outcomes, identifying key challenges and potential solutions in biomedicine.
• Developed a strong understanding of the factors influencing therapeutic efficacy and safety, including regulatory considerations and patient adherence.
• Investigated challenges in achieving optimal therapeutic outcomes, demonstrating problem-solving abilities and a critical approach to biomedical research.

Streamlining Regulatory Process: Mastering e-CTD software for dossier submission and enhanced approvals, Parul Institute of Pharmacy and Research, Vadodara, 02/12/24, 02/13/24, Two days workshop on 'Streamlining Regulatory Process: Mastering e-CTD software for dossier submission and enhanced approvals. About e-CTD, Document submission in electronic format as per different countries.

• PicFOP-International Conference on
  "Frontiers in Drug Delivery Systems and Biopharmaceutics: Revolutionizing Medicine" on 24th
  and 25th January 2025, organized by Faculty of Pharmacy, Parul University.
• International Conference on Sustainable Futures: Interdisciplinary Perspectives on Education and Technology 5.0 (SFIPT- 2025) organised by Vidyadeep University in Collaboration with The Institution of Engineers (India) - South Gujarat Local Center, SURAT, held on 24th-25th January 2025, at Anita, Kim, Surat, Gujarat, India.
• presented a poster entitled From Lab to Market: The Journey of Advanced Therapy Medicinal Products in Europe,
  The USA, And Australia.