Vineet Gavankar

Vineet Gavankar

Regulatory Affairs Consultant

Key Knowledge Areas:

  • EU submissions
  • New MAA applications
  • Post-approval maintenance
  • Gap analysis
  • eCTD, NeeS, ACTD

Contacter

Education

2010 : Msc in Pharmaceutical Analysis (University of Strathclyde, Glasgow, UK)

2009 : Bachelor’s in Pharmacy, (Bharati Vidyapeeth University, Pune, India)

 

About Vineet

 Vineet has extensive experience in Regulatory Affairs gained over the past 10 years.

He has been involved in various regulatory projects assisting start-up to international companies as Regulatory Affairs Professional.

Background/Previous experience

Prior to joining BlueReg, Vineet worked at Mylan Pharmaceuticals as Senior Regulatory Affairs Officer. During his previous positions at Mylan Vineet has covered a wide range of regulatory activities including preparation and submission of compliant dossiers for New Marketing Authorisation Applications (MAAs) and Post-approval maintenance.

 

Worked closely with third parties and in-house cross functional teams in order to prepare and submit high quality regulatory dossiers.

Prepared regulatory strategies for new MAAs, post-approval submissions and launching of new products. Managed XEVMPD submissions to EMA.

He has knowledge and expertise in different systems like Trackwise, Documentum, Novos, DocuBridge, eCTD Manager.

 

 

Prior to that, Vineet has been involved with Regulatory Affairs activities in Amdipharm Mercury Co. Ltd. and Reckitt Benckiser, Healthcare such as compliance, submission, gap analysis and dossier writing. 

 

Vineet moved to consultancy and joined BlueReg in January 2020 as a Regulatory Affairs Consultant based in UK.