Senior Executive- Pharmacokinetics

Sun Pharma is seeking a Senior Executive- Pharmacokinetics to contribute to research and development within their R&D1 Regulatory Affairs division. The role involves designing and reviewing pharmacokinetic studies, coordinating with CROs, and developing patient-based BA/BE studies for complex generics. The company emphasizes a supportive, collaborative environment focused on personal and professional growth.

Requirements

• Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission.
• Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols.
• Coordinate with CRO in India and outside India for finalizing biostudy pilot and pivotal study protocol for DCGI BE application.
• Develop protocol for patient based BA/BE studies & PD end point study for complex generics.
• Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.

Benefits

• Robust benefits