Analyzes sales results against sales plan for assigned territory to ensure that sales goals are achieved or exceeded. Consistently performs business reviews and prepares and submits periodic sales presentations to Region Director of Sales, as specified
Analyzes sales results against sales plan for assigned territory to ensure that sales goals are achieved or exceeded. Consistently performs business reviews and prepares and submits periodic sales presentations to Region Director of Sales, as specified.
The Sr. Manager, Biopharmaceutics will also design comparative research studies for human participants to test potential available treatment options for Alvogen pharmaceutical innovator & generic products.
The Manager is responsible for developing products for INDs and NDAs with minimal supervision that meets the expected FDA standards and can be successfully filed with USFDA. The primary focus will be on the development oral solid dosage form.
The candidate must have project management experience in the generic pharmaceutical industry and with generic development of solid oral dosage forms. Experience in soft gels, capsules, transdermal delivery systems, liquids, sublingual films, injectables a plus.
Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
Acts as an analytical SME for 3rd party product development using traditional and advanced analytical techniques including but not limited to HPLC, GC, Dissolution, IVRT, LC-MSMS, GC-MS, XRPD, Raman, FTIR, Microscopy, PSD, Viscosity, SEC etc.
Work closely with the accounting team to ensure accounting issues are appropriately identified, analyzed, documented in technical position memos and reported in external reports and internal presentations.