Executive - Pharmacokinetics

Roles & Responsibilities
• Conduct scientific literature searches and design BA/BE studies for oral and non-oral dosage forms
• Review BA/BE study protocols and provide pharmacokinetic and statistical inputs
• Coordinate with CROs (India and international) for pilot and pivotal bio-studies
• Develop protocols for patient-based BA/BE studies and pharmacodynamic (PD) endpoint studies
• Perform pharmacokinetic and statistical analysis using Phoenix WinNonlin software
• Interpret in-vivo PK data and support data review and reporting
• Provide support for regulatory submissions to DCGI and other global regulatory authorities

Qualifications
• M.Pharm in Pharmacokinetics, Pharmaceutics, or a relevant specialization

Experience
• 2–5 years of hands-on experience in BA/BE studies and pharmacokinetics
• Experience in in-vivo data analysis and regulatory support activities

Skills
• Strong working knowledge of Phoenix WinNonlin and PK/statistical analysis
• Good understanding of BA/BE study design and regulatory guidelines
• Ability to coordinate cross-functionally with CROs and internal teams
• Strong analytical, documentation, and communication skills
• Detail-oriented with a compliance-focused approach

About the Organization
Sun Pharmaceutical Industries Ltd is India’s leading pharmaceutical company with a strong global presence, focused on complex generics and specialty products. The organization offers robust R&D capabilities and career growth opportunities for professionals passionate about innovation and regulatory science.