Senior Executive- Pharmacokinetics

Sun Pharma · Vadodara, Gujarat · Refreshed 5 days ago

About this role

Job Title Senior Executive - Pharmacokinetics Business Unit R&D1 Regulatory Affairs Job Grade G11B Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description • 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 the 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. • 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) inp

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