Endo Pharma is seeking a highly motivated Regulatory Affairs Associate to join our team in Indore. This role is crucial in ensuring compliance with regulatory requirements for pharmaceutical submissions.
Key Responsibilities:
✔ Compilation and submission of Post Approval Supplements (PAS, CBE-0, CBE-30)
✔ Preparation, review, and submission of Amendments & Supplements for assigned products
✔ Handling responses to regulatory agency queries
✔ Compilation and submission of Global Annual Reports
✔ Review of stability protocols, analytical method validation reports, and batch records
✔ Ensuring compliance with raw material, packaging material, and finished product specifications
✔ Review of Process Validation Protocols, hold time studies, and Product Development Reports
✔ Verification of executed documents (BMR, COA) for regulatory compliance
About Endo Pharma
Endo Pharma is a leading global pharmaceutical company committed to improving patients’ lives through high-quality, affordable medicines. With a strong focus on regulatory compliance, innovation, and patient safety, we provide a dynamic work environment for professionals to grow and excel in their careers.
How to Apply
