Dadasaheb Salunkhe

About Dadasaheb Salunkhe

Dynamic & result oriented regulatory professional/ organic chemist with 24 years of immense experience in API research & development, technology transfer and high quality regulatory CMC submissions in spanning projects of various bulk drugs / intermediates from bothindigenous & MNC healthcare (API) organizations.Expertise understanding of CMC & Regulatory Affairs to aiddevelopment, licensure, manufacturing, and ongoing marketing ofpharmaceutical products with focus on consistency, effectiveness,safety and quality for consumersProven expertise in developing/ leading large teams andimplementing robust processes, leading to successful and timelycompletion of projects undertaken with strong focus on quality and instrict adherence to GMP guidelines.Demonstrated strong ability to formulate, lead & drive global CMCregulatory strategy for development projects and marketing productswith a focus on creativity & innovation, maximizing business benefitbalanced with regulatory compliance.Strong knowledge of regulatory requirements and market trends asdefined by Health Regulatory Authority in regulated markets like (US/EU/ ROW countries).Instrumental in developing, implementing & streamlining processes/systems for higher operational efficiency with expertise in managingrelation with internal as well as external stakeholders with an eye onbudgeted costs.Demonstrated ability to thrive in a deadline intensive environment,proactively identify problems, formulate tactical plans, initiatechange/s and effectively implementing programs in challenging anddiverse environments.

Experience

1. Associate Director-cmc

   MSD

   Jul 2025 — Present · Mumbai, IN

   Job Responsibilities:Development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.

Education

• Shivaji University

  Master of Science (M.Sc.), Chemistry

  1999 — 2001

• Shivaji University

  Ph.D., Synthetic Organic Chemistry

  2007 — 2012

• Shivaji University

  Bachelor of Science (B.Sc.), Chemistry

  1996 — 1999

Skills

• Regulatory Requirements
• Gmp
• Chemistry
• Uv/Vis
• Process Simulation
• Glp
• Pharmaceutics
• Drug Discovery
• Organic Synthesis
• Nmr
• Generic Programming
• Validation
• Medicinal Chemistry
• Uv
• Lc-Ms
• Dissolution
• Good Laboratory Practice (Glp)
• Organic Chemistry
• Technology Transfer
• Pharmaceutical Industry
• Sop
• Formulation
• Hplc
• Chromatography
• Anda
• Analytical Chemistry
• Regulatory Affairs