Medical Affairs Job at Amneal Pharmaceuticals
Are you passionate about transforming patient care through innovative pharmaceutical solutions? The medical affairs job at Amneal Pharmaceuticals 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. This medical affairs job will play a crucial role in advancing their mission.
Job Details:
- Location: Ahmedabad City, Gujarat, India
- Job Identification: 8329
- Job Category: Formulation R&D
- Apply Before: 17 August 2026
- Job Schedule: Full-time
Key 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 in this Medical Affairs Job in Gujarat
- 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.
Eligibility Criteria for the Medical Affairs Job:
Education:
- MBBS
Experience:
- 5 years or more in a relevant field
Required 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
