Assistant Manager

Compile, prepare, critically review and submit the US ANDAs for Inhalation dosage form, Sterile dosage form and Nasal Spray with highquality, following the regulatory guidelines and internal processes within time lines.
Ensure timely submission of all assigned projects. Ensure final US ANDA meets the requirement of latest ANDA checklist recommended by USFDA to avoid any acceptance to file issue. Prepare regulatory strategies for all assigned projects covering all key points. Work very closely with US regulatory Project mangers at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Submit controlled correspondence to FDA on specific issues as needed for assigned projects. Proactively raises major project issues to superior for resolution and agreement. Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies to avoid acceptable for filing issues.

Qualification : M.sc/M.Pharm

Designation : Executive to Assistant Manager