Role & responsibilities

- Manage BA/BE projects from feasibility to final study report.

- Review client requirements, molecules, dosage forms, strengths and reference products.

- Develop and review BA/BE study designs and protocols.

- Manage fasted, fed, single-dose, multiple-dose, crossover, replicate and parallel study designs, as applicable.

- Coordinate with clinical sites, investigators, bioanalytical laboratories, statisticians and external CRO partners.

- Manage study initiation, subject recruitment, dosing, PK sampling and study completion.

- Coordinate bioanalytical method validation and sample analysis.

- Review PK and statistical outputs, including Cmax, AUC.

- Review and coordinate preparation of clinical, bioanalytical, PK/statistical and final BA/BE reports.

- Coordinate Ethics Committee/IRB and regulatory requirements.

- Ensure compliance with applicable GCP, GLP and regulatory guidelines.

- Manage protocol deviations, CAPA,



study risks and project timelines.

- Handle client communications, technical discussions and project meetings.

- Support preparation of technical proposals, feasibility assessments and quotations.

- Manage CRO/vendor selection, qualification and performance.

- Monitor project budgets, timelines and deliverables.

- Prepare BA/BE project trackers and management MIS reports.

- Lead, mentor and train BA/BE team members.

- Support regulatory submissions and responses related to BA/BE studies.

Preferred candidate profile

- BA/BE Study Management

- Bioequivalence Studies

- Clinical Research

- Pharmacokinetics

- Protocol Development

- PK/Statistical Analysis

- Bioanalytical Coordination

- CRO/Vendor Management

- Project Management

- Regulatory Compliance

- GCP

- Client Management

📌 BA/BE Manager (Bengaluru)
🏢 Elite Biopharma
📍 Bengaluru