Bhupendra Sharma

  • Chennai TN
Bhupendra Sharma

Experienced regulatory operation professional with expertise in eCTD compilation, SPL creation, FDA submission and various strategic activity.

REGULATORY SUBMISSIONS | PROJECT CO-ORDINATION

Work History
Dec 2012 - Present

Executive

Hospira Healthcare India Pvt. Ltd.
  • Compilation and submission of new product registration application into CTD/eCTD as Variations/PSUR/Annual Reports to US FDA via. ESG
  • Publishing complex submissions (Original ANDA or MAA, Amendments and Supplements) using advanced electronic publishing systems and Submitting to US and EMA
  • Generating the .xml Output using eCTD submission process and tools as eCTD Xpress, ISI Publisher, ISI Tool box, Adobe Acrobat Professional 9.1.1, Adobe Acrobat Professional 11.0.10 and Nuance Pdf Converter
  • Uploading submissions to US FDA via Electronic Submission Gateway (ESG)
  • Creation of various Labeling documents into SPLr and PLR (Structured Product labeling and Physician Labeling Rule) formats using Virtx Software
  • Dedicatedly Involved in APQR Process, a requirement per ICH Q7
  • Actively Involved in Global Product Records creation using Trackwise software
  • Dynamically involved in Global Dossier Repository Management and Global
  • Submission Schedule Management


Other Activities:

  • Archiving (GDR) and Managing Database (as GPR, APQR) along with Internal and Global Associates
  • Reviewing various SPLr and PLR in quality and timely fashion
  • Drug listing various SPLr and PLR to Dailymed
  • Dedicatedly Involved in strategizing various process improvement initiatives
Jan 2012 - Sep 2012

Regulatory Affairs Chemist

ALPA Laboratories Ltd
  • Co-ordinating teams for project start ups and feasibility
  • Various regulatory support activities like submission co-ordination / Regulatory consultation at Pre-submission stage and during submission with team
  • Guiding CFT’s to develop a high quality product and technical documents for regulatory submission
  • Technically reviewing the documents like DMF’s, MFR’s, Specifications, Stability Data & CoAs etc. as per current regulatory requirements required for registration
  • Compiling dossiers as key team member for various regulatory activities
  • Handling customer and/or MoH Queries
  • Managing samples and other documents availability and their shipment

Skills

Skills

Regulatory Operations

Publishing complex submissions (Original ANDA or MAA, Amendments and Supplements) using advanced electronic publishing systems and Submitting to US and EMA

Structured Product Labeling

Creation of various Labeling documents into SPLr and PLR (Structured Product labeling and Physician Labeling Rule) formats using Virtx Software

Regulatory Submissions

Compilation and submission of new product registration application into CTD/eCTD as Variations/PSUR/Annual Reports to US FDA via. ESG

Regulatory Compliance

Dedicatedly Involved in APQR Process, a requirement per ICH Q7

Regulatory Intelligence

Creating Reports and updates on daily basis.

Education

Education
2009 - 2011

M.Pharm

RGTU

Master of Pharmacy (Pharmaceutical Chemistry) - RGTU, 2009-2011, Percentage - 78.60 %

2005 - 2009

B.Ph

RGTU

Bachelor of Pharmacy - RGTU, 2005-2009, Percentage - 75.04 %

Mar 2003 - Mar 2004

HSC

DAV Public School-CBSE Board

HSC - CBSE Board, 2004, Percentage - 63.40%

Apr 2001 - Mar 2002

SSC

DAV Public School-CBSE Board

SSC - CBSE Board, 2002, Percentage - 75.20%