Clinical Pharmacokinetics Analyst

Why This Role Matters

Pharmacokinetics (PK) plays a central role in the development, approval, and lifecycle management of pharmaceutical products. Accurate design and interpretation of Bioavailability (BA) and Bioequivalence (BE) studies directly impact regulatory approvals, product registration timelines, and market entry strategies.
This role is critical in ensuring scientifically sound PK evaluation, robust statistical analysis, and regulatory-compliant study designs for oral and non-oral formulations. By supporting BE applications and responding to regulatory queries, the position contributes directly to successful submissions and commercialization of products.

Job Description

The Executive / Senior Executive – Pharmacokinetics is responsible for literature evaluation, protocol development, pharmacokinetic analysis, and regulatory support for BA/BE studies. The role requires strong technical expertise in PK modeling, statistical analysis, and regulatory submission support.
The position involves close coordination with Contract Research Organizations (CROs), internal clinical teams, and regulatory stakeholders to ensure study optimization and compliance.

Key Features of the Role

• Involvement in design and execution of BA/BE studies for oral and non-oral products
• Exposure to regulatory submissions including DCGI applications
• Hands-on PK and statistical analysis using Phoenix software
• Use of modeling and simulation tools for study optimization
• Opportunity to work on complex generics and patient-based studies
• Interaction with CROs and regulatory teams

Responsibilities

• Conduct literature searches to support study design and regulatory strategy
• Design Bioavailability (BA) and Bioequivalence (BE) studies for various dosage forms
• Review BA/BE study protocols and provide Pharmacokinetic (PK) inputs
• Coordinate with CROs to finalize pilot and pivotal study protocols for DCGI BE applications
• Develop protocols for patient-based BA/BE studies and pharmacodynamic (PD) endpoint studies for complex generics
• Perform pharmacokinetic and statistical analysis of in-vivo data using Phoenix software
• Utilize modeling and simulation tools to optimize study design and outcomes
• Interpret PK data and generate reports for regulatory submissions
• Respond to regulatory queries related to PK analysis and study interpretation
• Ensure compliance with regulatory guidelines for bioequivalence studies

Required Qualifications

• Strong understanding of pharmacokinetics and bioequivalence principles
• Knowledge of regulatory requirements for BA/BE submissions
• Ability to interpret in-vivo PK data accurately
• Strong analytical and statistical skills
• Effective coordination and communication abilities

Educational Requirements

• M.Pharm or Pharm.D (mandatory)

Experience and Skills

• Minimum 3 years of relevant experience in Pharmacokinetics / BA-BE studies
• Hands-on experience in Phoenix software for PK analysis
• Exposure to DCGI regulatory submissions
• Knowledge of modeling and simulation techniques
• Experience in complex generic product development preferred
• Strong documentation and report writing skills
• Ability to manage multiple studies and timelines efficiently
• Proficiency in MS Office tools

Salary Insights

• Compensation depends on experience, expertise in PK modeling, and regulatory exposure
• Professionals with hands-on BA/BE statistical analysis and DCGI submission experience typically fall within mid-level compensation brackets
• Senior-level candidates with modeling expertise may command higher salary positioning

Company Overview

Sun Pharma is one of the world’s leading specialty generic pharmaceutical companies, committed to delivering high-quality, affordable medicines globally.
With a strong presence across multiple therapeutic segments and global markets, Sun Pharma focuses on innovation, regulatory excellence, and continuous improvement. The organization promotes a culture of growth, accountability, and collaboration, encouraging employees to take ownership of their professional journey while contributing to impactful healthcare solutions.

FAQs

• Is Phoenix software experience mandatory?
Yes, hands-on experience in PK analysis using Phoenix is required.

• Does this role involve regulatory interaction?
Yes, responding to regulatory queries and supporting DCGI submissions is part of the role.

• Is experience in complex generics required?
It is preferred, especially for patient-based BA/BE and PD endpoint studies.

• Will coordination with CROs be required?
Yes, the role involves active coordination with CROs for protocol finalization and study execution.

Application Tips

• Highlight specific BA/BE studies you have designed or analyzed
• Mention experience with DCGI or other regulatory submissions
• Showcase proficiency in Phoenix and modeling tools
• Demonstrate your understanding of statistical analysis in PK studies
• Provide examples of regulatory query responses or study optimization contributions