AGM/ GM - Regulatory Affairs ( EU & US ) - Pharmaceutical Industry

GenNext Human Resource Management
  • Mumbai
  • Confidential
  • 12-20 years
  • 15 Sep 2015

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Provide technical guidance to R&D and supporting departments for validation studies to be conducted for filings
Designate the acceptable starting material for filling DMF
Issuing of Letter of Access to DMF submitted to various Regulatory Agencies
Ensure timely submission of customer and regulatory queries
Conduct training programs to upgrade cGMP awareness, Regulatory updates in organization
Reduce response time, reduce repetitive queries from customer / Regulatory queries
Ensure error-less filings of DMF/ product master file / Technical data package
Ensure error-less / quality response to market complaints
Ensure DMF updates and variation application on time with agencies

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