Manager - 1 Job in Sun Pharmaceutical Industries Ltd

Manager - 1

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Job Summary
  • Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products(injectable, Semisolids, TDS etc.) towards different regulatory submission.
  • Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols
  • Developing protocol for patient based PK end point & also for PD/Clinical end point BE studies for complex generics.
  • Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.
  • Coordinate with the CRO in India and outside India for finalizing biostudy pilot and pivotal study protocol for DCGI BE application.
  • Preparation of pharmacokinetic queries response, scientific justification for study design/ protocol/ results towards various regulatory agencies for their concurrance or advice.
  • Having in-depth understanding of in-vitro parameters and indentification of critical variables impacting the in-vivo release. Perform IVIVC, simulation and Pharmacokinetic modelling to improve BE success.
  • Experience Required :

    Fresher

    Vacancy :

    2 - 4 Hires

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