S Naveen Kumar

Experience

• 

  Bal Pharma Limited

  Sept 2007 - May 2008

  Trainee: Chemist

  Performed dissertation project on Isolation, Synthesis & Characterization of Impurities Related to Letrozole under the guidance of Dr. Nagarajan.Involved extensive exposure to different synthetic reactions along with characterization of chemical compounds using H-1 & C-13 NMR, Mass Spectroscopy, Infrared Spectroscopy & Liquid Chromatography.

• 

  Medreich Limited

  Oct 2008 - Jan 2010

  Regulatory Affairs Officer

  Worked as a Regulatory Affairs Officer compiled dossiers for highly regulated markets of TGA, MHRA and New Zealand; semi & non regulated markets of Tanzania, Sudan, Sierra Leone, Kenya, Madagascar etc.Maintained MIS for the smooth functioning of the regulatory department.Answered queries raised by various MOH.Was a part of corporate communications.

• 

  PharmaLeaf India Private Limited

  Jan 2010 - May 2012

  Junior Associate Manager- Regulatory Affairs

  - Was responsible for successful submission of an improved generic formulation in the EU.- Was deputed as lead FTE at AstraZeneca for their new branded generics portfolio- managed and successfully coordinated for submission of 60 dossiers in various countries including South Africa, Gulf Countries, Russia, Ukraine, Thailand, Vietnam etc.- Acted as CMC Regulatory Expert providing vital inputs during development stages of generics and improvised generics

• 

  Biocad India Private Limited

  May 2012 - Dec 2012

  Regulatory Affairs Manager

  Worked as Manager Regulatory Affairs at Biocad India Private Limited during it's nascent stages.Was responsible for filing of One Import Registration Application and Two BE/CT applications for India.Provided regulatory intelligence inputs for designing product portfolios in various Asian countries.Was part of CRO shortlisting in ASEAN countries.Established IT systems and servers for connectivity of the India office with the head quarters.

• 

  PharmaLeaf India Private Limited

  Dec 2012 - Mar 2016

  Manager Regulatory Affairs & Quality Assurance

  Worked as a Manager, Regulatory Affairs. Provided technical consulting to top 7 multinational pharmaceutical companies expand their footprints. Managed regulatory projects and dossier filings across markets including EU, ASEAN, Middle East and North Africa, CEECIS countries & India

• 

  IQVIA

  Mar 2016 - Mar 2019

  • Senior Regulatory Affairs Officer

    Jul 2018 - Mar 2019

  • Regulatory Affairs Officer

    Mar 2016 - Jun 2018
• 

  Parexel

  Mar 2019 - now

  • Senior Manager, Regulatory & Access

    Nov 2021 - now

  • Manager, Regulatory & Access

    Mar 2019 - Nov 2021