- Identify potential drug molecules suitable for 505(b)(2) development based on scientific, clinical, and commercial rationale.
- Critically review published and regulatory data (PK, safety, efficacy, bioavailability) from approved products, literature, and databases.
- Assess clinical unmet needs and define opportunities for improved formulations (e.g., long-acting injectables, depot systems, novel delivery platforms).
- Propose formulation strategies aligned with pharmacokinetic and therapeutic objectives.
- Support development of clinical and regulatory strategies for 505(b)(2) submissions.
Additional Responsibilities : Education :
- MBBS
Experience :
- 5 years or more
Amneal is an equal chance employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.