Amneal Pharmaceuticals is seeking an experienced Executive, Regulatory Affairs (Injectable) to join their team in Ahmedabad. This role involves ensuring compliance with regulatory standards for General and Complex Injectable Products.
Key Responsibilities:
- Compilation & Review of quality ANDAs (Abbreviated New Drug Applications) for Injectable products within deadlines.
- Handling Amendments (DRL/IR/CR) for Amneal Injectable products as per regulatory timelines.
- Reviewing technical documents from PD, ARD, QA, QC, Production, and CRO for dossier submission.
- Coordinating with cross-functional teams to complete regulatory tasks efficiently.
- Preparing regulatory strategies, white papers, and addressing critical gaps in consultation with superiors.
- Reviewing DMFs (Drug Master Files) for Injectable APIs and coordinating with vendors.
- Drafting and reviewing Controlled Correspondences for Injectable products.
- Liaising with CMOs (Contract Manufacturing Organizations) for external development projects.
- Collaborating with R&D, ARD, QC, QA, Clinical, and Labeling teams to resolve technical issues.
- Monitoring changes in regulations, guidelines, and compliance requirements affecting product lifecycle.
- Maintaining a global regulatory database for documentation and archival.
Qualifications & Skills
- Master’s Degree in Pharmacy, Life Sciences, or related field.
- Strong knowledge of regulatory submissions (ANDAs, DMFs, Amendments).
- Experience in Injectable (Parenteral) formulations is preferred.
- Familiarity with USFDA, EMA, and other global regulatory guidelines.
- Excellent communication, coordination, and project management skills.
About Amneal Pharmaceuticals
Amneal is a leading global pharmaceutical company specializing in generic and specialty medicines. Committed to innovation and affordability, Amneal ensures high-quality healthcare solutions worldwide.
Why Join Amneal?
✅ Equal Opportunity Employer – No discrimination based on caste, religion, gender, or disability.
✅ Inclusive Work Culture – Diverse and collaborative environment.
✅ Career Growth – Opportunities in regulatory affairs, R&D, and global compliance.
How to Apply?
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