Rajeev Agarwal

Experience

• 

  Eli Lilly and Company

  Jun 2003 - Feb 2004

  Study Coordinator

  All logistic, administrative and trial related aspect in line with ICH/ GCP expectations including site management.

• 

  Ranbaxy Laboratories Ltd.

  Mar 2004 - Mar 2014

  Medical Affairs and Clinical ResearchPharmacovigilance: Preparation of Periodic safety Update Reports (PSURs) for submission to Indian regulatory (DCGI) and EU Regulatory Authorities.Medical Affairs: Preparation of various regulatory documents viz PI, SmPC, Pre-clinical expert reports, Technical reports, Medical data packages as per regulatory requirements.Clinical Research: Extensively involved in executing phase II, III b and IV clinical trials for New Chemical Entities (NCEs), New Drug Delivery System (NDDS) products and Fixed Dose Combinations (FDCs). Show less

  • Senior Research Scientist(A3)

    Aug 2013 - Mar 2014

  • Senior Research Scientist(A3)

    Jan 2011 - Jul 2013

  • Senior Research Scientist (A2)

    Jan 2009 - Dec 2010

  • Research Scientist

    Jan 2007 - Dec 2008

  • Research Scientist

    Mar 2006 - Dec 2006

  • Research Associate

    Mar 2004 - Feb 2006
• 

  SUN PHARMA

  Apr 2014 - Nov 2015

  Senior Research Scientist

  Regulatory AffairsFrom April 2013 to Nov-2015: Involved in filing of new registration dossiers, to Middle East countries including Gulf Cooperation council (GCC)( both central & national filings),Re-registration, variations and life cycle management etc. Mentored 03 scientist/Sr. scientist.

• 

  Mylan

  Dec 2015 - Feb 2022

  Develop Regulatory strategy for assigned projects and countries by designing and assessing regulatory strategy options on a regional/global basis (as outlined in the Global Regulatory Plan) in collaboration with local/regional regulatory teams.• Pre-registration activity: Involved in registration of dossiers to Middle East, North Africa, Russia, Mexico, Turkey and South Africa. • Post Registration activity: Renewals and variations etc. Ensure smooth operation of Regulatory by planning, review and co-ordination for the submission of:• New registration dossiers filing. To communicate and coordinate with different stakeholders to resolve any delay in submission.• Deficiency management: Timely response of the deficiencies raised by the Agency. With this timely approval and launch can be planned.• Life cycle management i.e renewal and filing of variations. • Evaluate change control and provide regulatory input including variation category, data expectation, expected approval time and expected implementation timeline of proposed change(s).• Manufacturing site registration/Re-registration (Renewal of site registration).• Coordinate with launch team for launch of budgeted products. Ensure compliance at manufacturing location(s) by providing / or updating approval packages of drug products. • Co-ordinate with Pharmacovigilance team for PSUR and RMP as applicable.• Enlighten the regulatory knowledge of subordinates by providing on job training.Due diligence of 3Party dossiers: Due diligence of 3P products for Asia, Middle East, North Africa, Africa, Latam, CIS countries, Mexico and South Africa markets. Show less

  • Assistant General Manager

    Mar 2019 - Feb 2022

  • Senior Manager

    Dec 2015 - Feb 2019
• 

  Viatris

  Mar 2022 - now

  Deputy General Manager