• 1-2 Years CTA preparation and Compilation. Experienced with preparation/review of Clinical Trial Authorization Packages for India
• Awareness of regulatory requirements
• Review and evaluate technical and scientific data and reports required for submission
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards Co-ordinate with global team for documentation
• Responding to queries raised by regulatory authorities
• Maintain regulatory files in a format consistent with requirements
• Label reviews
• Tracking submissions
• CTRI registration
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
Experience: 1-2 years
Qualification: B.Sc, B.Pharm
Location: Bengaluru, Karnataka
Functional Area: Regulatory Affairs
Industry Type: Pharma
Job ID : 44545BR
End Date: 25th July, 2018
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