Manager/ Sr. Manager - Drug Regulatory Affairs

GenNext Human Resource Management
  • Mumbai
  • Confidential
  • 10-18 years
  • 03 Aug 2015

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Responsible for planning and management of regulatory submissions to US-FDA, Europe, Australia, Canada, South Africa, Brazil and other global health authorities.
Responsible for product Dossier Preparation and Submission in CTD and eCTD format in US
Experience of ANDA for mixed dose combination in US & EU markets
Should able to compile dossiers for regulated market in CTD / e CTD format, should able to handle queries of FDA, review of data.

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