Exciting Medical Affairs Job at Amneal Pharmaceuticals | MBBS Candidates Apply!

Are you passionate about transforming patient care through innovative pharmaceutical solutions? This role focuses on identifying and evaluating drug candidates suitable for development via the 505(b)(2) regulatory pathway. The successful candidate will leverage existing clinical, safety, and efficacy data of approved products to propose differentiated formulations that address unmet clinical needs.

About Amneal Pharmaceuticals

Amneal Pharmaceuticals is a leading global pharmaceutical company headquartered in the United States, specializing in the development and manufacturing of generic and specialty pharmaceuticals. The organization is committed to improving patient outcomes through high-quality, affordable medications. With a strong presence in the pharmaceutical sector, Amneal is dedicated to addressing unmet clinical needs through innovative solutions.

Location: Ahmedabad City, Gujarat, India
Job Category: Formulation R&D
Schedule: Full-time
Apply Before: 17 August 2026

Responsibilities

• 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.
• Collaborate with formulation R&D, regulatory, and business teams to prioritize development candidates.
• Prepare scientific justifications, gap analyses, and development proposals for internal decision-making.

Requirements

• MBBS degree
• 5 years or more of experience in a relevant field

Skills

• Analytical Thinking & Problem-Solving
• Clinical Trials
• Cross-functional Collaboration
• Data-Driven Decision Making
• Regulatory Compliance
• Risk Assessment & Control
• Scientific & Clinical Research
• Stakeholder Management
• Strategic & Operational Planning
• Technical Documentation