Experience

• 

  GCC Biotech (India) Pvt. Ltd.

  • Kolkata, West Bengal, India

  • Chief Scientific Consultant

    • Mar 2021 - Present
    • Kolkata, West Bengal, India

     Leading overseas business development and expansion plans with special to south Asian countries and Gulf countries. Scientific consultation for development and validation of new diagnostic kits. Based on business requirement advisory for the Layout and construction of new vaccine facility project. GAP identification and close out with regards to CDSCO requirement and CEIVD requirement for diagnostic kits. Guideline for preparation of obtaining CDSCO Licences for various diagnostic kit and panels.  Existing Facility improvement and system stabilization.

• 

  ACG World

  • Mumbai, Maharashtra, India

  • Head Global Regulatory Affairs

    • Feb 2016 - Jun 2019
    • Mumbai, Maharashtra, India

    Strategizing business expansion plan and goals inline with organizational objectives.  China Dossiers fillings, MFDS Korea fillings and approvals. US FDA GRAS preparations and presentations to US FDA. Third party consultant evaluation and on boarding.  Implementation of eCTD within organization as per USFDA requirement.  Liaison with Indian FDA. Support in products filings.  Technical Inputs on Pharmacopeial monographs for updation and inclusions e.g. USP, IP etc Support to manufacturing sites for Regulatory Inspections and Compliance

• 

  Sun Pharmaceutical Industries Limited (erstwhile Ranbaxy Laboratories Limited)

  • Gurgaon, India

  • Group Leader

    • Jun 2007 - Dec 2015
    • Gurgaon, India

    Pre-approvals - New generic submissions for South Africa and Rest of Africa and Post approvals - Variations, supplements, query responses, renewals/ registration, life cycle management and regulatory compliance for regulated markets.  Managing execution of the pilot scale/ test/ pivotal Batch manufacturing Process Optimization / Process Feasibility of new products for all formulation manufacturing locations, Initiation of process optimization plan, Test batch manufacturing plan and compilation of process optimization summary. Skillful in supervising & directing overall production operations & ensuring accomplishment of pre-set production targets within stipulated time and cost parameters.  Adept in implementing effective strategies for reducing production expenditure & energy consumption.  Proficient in undertaking process enhancement, process modifications and equipment calibrations / re-qualifications to enhance operational efficiency and thereby escalating productivity. Possess excellent interpersonal, analytical, troubleshooting and team building skills with proven ability in establishing transfer of technology with quality systems/ procedures and managing resources.

• 

  Bangalore

  • Strides Arcolab Limited

    • Feb 2005 - May 2007

• 

  SUN PHARMA

  • Jammu Area, India

  • Production Executive

    • Apr 2004 - Feb 2005
    • Jammu Area, India

• 

  LUPIN LIMITED

  • Mandideep

  • Production Supervisor

    • Aug 1999 - Sep 2001
    • Mandideep