Dr. Reddy’s Laboratories is a leading multinational pharmaceutical company headquartered in Hyderabad, India. Founded by Kallam Anji Reddy, the company specializes in manufacturing and marketing a broad range of pharmaceutical products, including over 190 medications, 60 active pharmaceutical ingredients (APIs), diagnostic kits, critical care solutions, and biotechnology-based products. With a strong global presence, Dr. Reddy’s Laboratories is committed to innovation, quality, and affordability in healthcare.
Responsibilities in Job As a PK Scientist – Clinical Pharmacokinetics, the selected candidate will be responsible for:
- Preparation of Synopsis for BE Studies: Developing and reviewing synopses for bioequivalence (BE) study protocols across various geographies.
- Regulatory Submissions: Reviewing and submitting BENOC protocols for Drug Controller General of India (DCGI) approval.
- Clinical Pharmacokinetics (CPK) Inputs: Providing expert inputs for pre-apex products.
- Review and Compilation of Biostudy Reports: Ensuring timely submission of pilot BE study reports to regulatory affairs (RA), including eCTD review and compliance.
- Investigational Product (IP) Handling: Coordinating with PDTs to arrange and ship IPs to Contract Research Organizations (CROs) for pilot and pivotal BE studies.
- Statistical Analysis: Preparing statistical analysis reports of BE studies for allocated projects.
- Coordination with CROs: Engaging with CROs and vendors for smooth execution and monitoring of BE studies.
Qualifications
- Postgraduate degree in Pharmacy (M.Pharm)
- Strong knowledge of Clinical Pharmacokinetics, Clinical Research, GCP/GLP, and BA/BE Studies
Skills Required
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- Expertise in clinical pharmacokinetics and bioequivalence studies
- Strong analytical and regulatory documentation skills
- Excellent coordination and communication abilities
- Experience with statistical analysis of clinical data
- Familiarity with regulatory submission processes (eCTD, DCGI, etc.)
