Ankit Dutta

About Ankit Dutta

An experienced professional in domain of pharmacovigilance and regulatory affairs. Experience on ICSR case processing and reviewing of all types of cases (spontaneous, PMS, literature,e2b etc). Experience on triaging of cases and processing RAVE clinical trial cases. Expertise on RAW material qualification to world wide regions (APAC,NA,LATAM,EMEA), Impact and toxicological assessment for impurity profile in RAW materials. Expertise in regulatory requirements for all type of RAW materials (synthetic, botanical, flavour, fragrance,plants,animal derived, and minerals).

Experience

1. Senior Regulatory Affairs Specialist

   Labcorp

   Aug 2022 — Present

   Working in RMQ/SPECright database for filling and ensuring raw materials information regarding various certifications, regionwise requirements are kept updated on a timely basis. To update expired certifications, statements, specifications, toxicological summary, also composition and impurity statement etc for a RAW material-Working in Concerto database to route RAW and get them approved from regulatory and toxicological team which impacts the labelling for that Raw material-Working on TRU database for various data mining activities with respect to Raw materials, generation of Where use reports to identify the intended selling region for individual RAW material

Education

• Calcutta Institute of Pharmaceutical Technology and Allied Health Sciences

  Graduate in B.pharma, Bachelor in Pharmacy

  2012 — 2016

• St.stephens School

  ISC, Bio-science, 72%

  2011 — 2012

• St.stephens School

  ICSE, 79 %

  2009 — 2010