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Regulatory Affairs Manager

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  • Posted By: MSR Placements, Ahmedabad
  • Address:
  • Date Posted: 28th Aug 2010
  • Salary: negotiable
  • Location: Naranpura (380001)
  • Reference Code:
  • Views Since Posting: 75
  • Full Description:


Preparation and submission of marketing authorization applications, variations and renewals for EU and US (ANDA) within planned time frames.

Manage DCP, MRP, EU national applications, ANDA and NDA.

Responsible for eCTD submission of dossiers

Review of Chemistry Manufacturing and Control (CMC) documents for quality part of CTD

Good knowledge on ICH, FDA guidances, EU and non-EU regulations

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