AUROBINDO PHARMA LTD (APL) is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.
Post : CPD Department Manager
Job Description
• Design of IVPT/IVRT studies for compliance to regulatory requirements
• Review of study protocols for IVPT/IVRT studies and their adequacy and compliance to regulatory requirements.
• Review of method development data and method validation data for adequacy and compliance to regulatory requirements, prior to apply for IVPT/IVRT studies.
• Planning and monitoring of IVPT/IVRT studies at CROs
• Review and evaluation of study data and interpretation of the study results
• Handling of regulatory queries and preparation of query responses
Candidates for Derma – Clinical Pharmacology Department with Qualification – M.Pharmacy, 10-12 years of experience in IVRT/ IVPT studies on Derma Products with Experience & expertise on IVRT / IVPT studies to establish bioequivalence for Derma Products, good at regulatory knowledge and handling of regulatory queries.
Job Location : Pashamylaram, Hyderabad
Interested candidates with relevant experience can send their profiles to pallavi.gottumukkala@aurobindo.com
Please mention in the subject: Derma – IVRT / IVPT requirement
See All Ph.D Alerts M.Pharm Alerts B.Pharm Alerts MBA Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
