Job Description
• Experienced with preparation/review of Clinical Trial Application Packages
• 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.
• Experienced with preparation/review of Clinical Trial Application Packages
• 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.
Candidate Profile
Graduate, Post-Graduate in Pharmacy, Biotech, Life Sciences
Over 4 years experience with preparation of CTAs.
Graduate, Post-Graduate in Pharmacy, Biotech, Life Sciences
Over 4 years experience with preparation of CTAs.
Additional Information:
Location: Bengaluru, Karnataka, India
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Job ID : 52345BR
End Date: 25th May, 2019
Location: Bengaluru, Karnataka, India
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Job ID : 52345BR
End Date: 25th May, 2019
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