Deputy Manager - Pharmacokinetic Modelling and Simulation Scientist Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, all india

On-site

Role Overview: As a Pharmacokinetic and Pharmacodynamic Modelling Scientist, you will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models to support drug development programs. You will work closely with cross-functional teams to guide decision-making and project direction. Additionally, you will be using advanced statistical approaches for bioequivalence analysis and large-scale data handling. Key Responsibilities: - Develop, validate, and apply pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling). - Conduct pharmacokinetic modelling and simulation analysis for project advancement. - Predict human pharmacokinetics based on diffe...

Posted 6 days ago

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Associate Director, Complex Gx, Regulatory Affairs Teva Pharmaceuticals

14.0 - 20.0 years

40 - 60 Lacs

bengaluru

Hybrid

Role & responsibilities Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays. Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals. Represent Regulatory Affairs in...

Posted 3 months ago

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Deputy Manager - Pharmacokinetic Modelling and Simulation Scientist Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as Win...

Posted 3 months ago

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