Dr. Reddy’s Laboratories is a leading Indian multinational pharmaceutical company headquartered in Hyderabad. Founded by Dr. Kallam Anji Reddy, the company specializes in manufacturing and marketing a wide range of generic drugs, active pharmaceutical ingredients (APIs), and biotechnology products. With a presence in over 60 countries, Dr. Reddy’s is known for its innovation in critical care, diagnostics, and biosimilars.
Job Description: PK Scientist – Clinical Pharmacokinetics
The PK Scientist will play a crucial role in clinical pharmacokinetics, bioequivalence (BE) studies, and regulatory submissions. The position involves protocol preparation, data analysis, and coordination with CROs to ensure compliance with GCP/GLP guidelines.
Key Responsibilities:
✔ Synopsis & Protocol Preparation
- Prepare synopses for BE study protocols across different geographies.
- Review and submit BE NOC protocols for DCGI (Drugs Controller General of India) submissions.
- Provide Clinical Pharmacokinetics (CPK) inputs for pre-APEX products.
✔ Bioequivalence (BE) Study Reports
- Review pilot BE study reports for regulatory submissions.
- Ensure clinical domain accuracy, eCTD compliance, and timely submission to Regulatory Affairs (RA).
- Conduct gap assessments for BE study reports.
✔ Investigational Product (IP) Handling
- Coordinate with Product Development Teams (PDTs) to ensure IP availability.
- Manage shipments to CROs for pilot & pivotal BE studies.
✔ BE Results Compilation & Analysis
- Perform statistical analysis of pilot & pivotal BE studies.
- Ensure data accuracy for regulatory filings.
✔ Coordination with CROs & Vendors
- Liaise with Contract Research Organizations (CROs) for BE study execution.
- Monitor study progress and ensure compliance with timelines.
Qualifications & Skills Required
✅ Post-graduation in Pharmacy (M.Pharm/Pharm.D)
✅ Strong knowledge of Clinical Pharmacokinetics, BA/BE studies
✅ Familiarity with GCP/GLP guidelines
✅ Experience in regulatory submissions (DCGI, eCTD)
✅ Analytical skills for BE study data interpretation
