- Collate and review CMC documents (e.g., Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports) from F&D, ADL, QA, production, and packaging departments. Review data for ANDA preparation, deficiency responses, annual reports, and supplements.
- Prepare and review ANDA sections.
- Compile controlled correspondences for excipients, Q1/Q2 queries, BE guidance, and general queries to the FDA.
- Assist in the development of regulatory strategies and their implementation to manage complex issues that may significantly impact the Company’s internal and external product portfolio and product approval process.
- Conduct knowledge sharing sessions as needed.
Endo Pharma
1 Year
25,000 - 35,000 /month
India
M.Pharm
Job highlights
Work/Life Balance
Time management
Flexibility
Problem Solving
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