1. Summary of Job Purpose

Provide hands-on physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) support across the full project lifecycledesign, planning, execution, and reporting—focused on generic drug development and 505(b)(2) regulatory submissions. Apply advanced M&S; expertise to enable biopharmaceutics risk assessment, support complex regulatory strategies, justify biowaivers, through highquality modeling deliverables aligned with global regulatory expectations (USFDA, EMA).

Support internal and external stakeholders by driving the adoption of PBPK/PBBM approaches for formulation development, bridging strategies, and alternative BE justification.

2. Qualifications & Experience
- Master’s degree in pharmaceutical sciences, pharmacokinetics, or related discipline (advanced degree preferred).
- Significant experience in:
- PBPK/PBBM modeling for generics or 505(b)(2) applications
- Biopharmaceutics, PK data analysis, and clinical pharmacology
- Experience designing and interpreting studies supporting BE, formulation bridging,



or biowaiver strategies.
- Familiarity with regulatory expectations for PBPK submissions (FDA MIDD, EMA PBPK guidelines).

3. Main Tasks & Responsibilities
- Build, verify, and refine PBPK/PBBM models to support:
- Formulation development
- BE risk assessments
- Virtual BE simulations
- 505(b)(2) bridging strategies
- Conduct parameter sensitivity analyses and uncertainty evaluations relevant to regulatory decision-making.
- Maintain expertise in PBPK/PBBM software (e.g., PKSim, GastroPlus, Simcyp), and PK analysis tools (Phoenix WinNonlin).
- Perform IVIVC/IVIVR assessments using mechanistic absorption models and traditional deconvolution approaches.
- Generate high-quality modeling reports suitable for regulatory submission.
- Present modeling outcomes to internal teams, and regulatory-facing project groups.
- Contribute to scientific publications, posters, and conference presentations.

📌 Cipla - Team Member - Iviivc (Mumbai)
🏢 Cipla
📍 Mumbai