• 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.

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