Team Member - BiopharmPK- IVIVC- PBPK

Cipla · Mumbai, Maharashtra

About this role

Division Department Sub Department 1 Job Purpose Provide advanced Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modeling (PBBM) support across the drug development lifecycle, contributing to biopharmaceutics risk assessment, formulation strategies, and regulatory submissions for global markets. Key Accountabilities (1/6) Develop and apply PBPK/PBBM models to support drug development. • Build, verify, and utilize PBPK/PBBM models to assess biopharmaceutics risks, perform virtual bioequivalence (BE) studies, and guide formulation development Conduct sensitivity and uncertainty analyses, perform in vitro-in vivo correlation (IVIVC) and in vitro-in vivo relationship (IVIVR) studies, and generate submission-ready documents to streamline regulatory processes Key Accountabilities (2/6) Support regulatory strategies and global submissions • Collaborate with cross-functional teams to apply PBPK/PBBM approaches in preparing robust regulatory submissions, aligned with global requirements such as USFDA and EMA guidelines Justify biowaivers effectively to minimize the need for costly BE studies, thereby optimizing timelines and resource utilization Key Accountabilities (3/6) Promote adoption of PBPK/PBBM approaches. • Build awareness and drive implementation of PBPK/PBBM frameworks by partnering with internal stakeholders and collaborating with external technical consultants Provide solutions for project challenges and ensure seamless integration

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