Akash Chachar

Regulatory Affairs Executive

Role
Regulatory Affairs Executive at Biocon
Location
Mumbai, MH, IN
LinkedIn followers
500 followers
Research & DevelopmentView LinkedIn profile

About Akash Chachar

I am currently working as Regulatory Affairs Executive (Biologicals) handling ROW/Emerging markets.

Experience

  1. Regulatory Affairs Executive

    Biocon

    Jul 2010 — Present · Bangalore, IN

    KEY RESPONSIBILITIES:Compilation of Country Specific/CTD/ACTD/IMPD product registration dossiers for submission in Emerging/Regulated/ROW Markets.Compilation of Technical Dossier for Tender participation. Submission of response to Queries/Deficiencies raised by Customers/Regulatory Authorities/Agents.To review drug product artworks like PI, SmPC and Carton.To work with cross functional teams such as QA, QC, Production and R&D for updating regulatory documents.Updation of all regulatory guidelines regularly.

Education

  • Shivaji University

    B.Pharm

    2004 — 2008

Skills

  • Protein Chemistry
  • Generic Programming
  • Hplc
  • Quality Assurance
  • R&D
  • Pharmaceutics
  • Drug Discovery
  • Pharmacovigilance
  • Quality Control
  • Gmp
  • Pharmacology
  • Pharmaceutical Research
  • Pharmaceutical Industry
  • Biologics
  • In Vitro
  • Anda
  • Regulatory Submissions
  • Regulatory Requirements
  • Uv
  • Biotechnology
  • Drug Delivery
  • Regulatory Affairs

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Akash Chachar — Regulatory Affairs Executive at Biocon in Mumbai, MH, IN | Unifers