Dhananjay Narute

About Dhananjay Narute

Global Regulatory Expert in Branded and Generic medicines with strategic oversight across…

Experience

1. Global Regulatory Affairs

   Glenmark Pharmaceuticals

   Sep 2022 — Present · Maharashtra, IN

   Providing strategic regulatory expertise related to CMC activities for small and large molecules through all stages of a product’s lifecycle & develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities.• Interfacing with the US FDA, EMA, TGA and Health Canada for CMC submissions and CMC-related issues.• Managing content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: New marketing applications for NDA and Generic products; HA responses & background packages (including participating / leading HA meetings); and/or post-approval submissions. • Performing regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for Complex Injectables and Respiratory Formulations and provides compliance documents to support Health Authority submissions. • Supporting project matrix teams for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects.• Provide strategic CMC regulatory expertise for development project teams and and commercial teams to mitigate drug supply issues.• Interpreting global regulations and guidance and participating in product fact finding meetings.

Education

• Bharati Vidyapeeth, Kolhapur

  B. Pharmacy

  2004 — 2008

• M. Pharm. (Pharmaceutics)

  M. Pharm. (Pharmaceutics)

  2008 — 2010

Skills

• Anvisa
• Abbreviated New Drug Application (Anda)
• Pharmaceutical Research
• Regulatory Affairs
• Fda
• Ectd
• Generic Programming
• Emea
• Analytical Method Validation
• Ich Guidelines
• Formulation
• Pharmaceutics
• Ctd
• Anda
• Regulatory Requirements
• Regulatory Submissions