Pharmacokinetics and Feasibility

Role & responsibilities

Key Responsibilities:
1-Assess regulatory requirements (FDA, EMA), study design, and sample size.
2-Identify appropriate demographics for target groups.
3-Conduct literature reviews for data compilation.
4-Respond to scientific and regulatory queries related to feasibility.

Skills Required:
1-Knowledge of FDA, EMA, and ICH guidelines.
2-Strong analytical and statistical skills for study design and data analysis.
3-Understanding of pharmaceutical dosage forms and BABE study planning.
4-Good communication skills for interaction with cross-functional teams.

Preferred candidate profile

2+ years of experience in feasibility evaluation for BABE studies.
M. Pharmacology or relevant qualification.