Suchandra Chakraborty Email & Phone Number

Experience on dossier authoring (M1, M2, M3), for regulated market (EU) and ROW market.Gap analysis and risk assessment for the submission based on available data/document on change in regulatory guidance.Review of protocols, reports, validation plans, development reports, DMFs, artworks and other CMC documents for submission of variations.Compiling handling and responding to regulatory authority queries.Co-ordination with cross functional teams, different interfaces of R&D and business functions to ensure project specific regulatory strategy to meet agreed timeline for submission.Assessment of quality and safety related changes, Life Cycle Maintenance to ensure timely post approval regulatory activities.Maintaining registration tracking information and assist in the development of good document management practices.Basic knowledge of incident management, change management, periodic review, vendor management, quality management review procedures, CAPA, deviations related to pharmaceutical organizations. Support to QA, during audits and inspections as required.Maintaining a strong client focus by effectively serving client needs and developing productive client relationship.

• 

  National Institute Of Technology Durgapur

  8