Description:
Essential Functions:
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 prospects 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 prospect 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.