Regulatory Affairs Specialist is needed to perform the following duties: o Prepare, review, and submit regulatory submissions to the FDA including NDA’s and ANDA’s. · Assist in developing and implementing submission strategies for NDA (both 505(b)1 and 505(b)2) and ANDAs · Assist in planning, writing and review of all regulatory submissions to support original IND, 505(b)1, 505(b)2, ANDA · Assist […]
Identify and develop new business strategies for long term sustainable revenue generation; gather data on competitors, prices and sales; provide key market inputs to management regarding potential products/markets for veterinary prescription and veterinary OTC pharmaceuticals; interact with CMO/CRO (Contract Manufacturing Organization/Contract Research Organization) to plan projects from execution to completion; identify new manufacturers to partner […]
2 Tower Center Blvd., Suite 1101A
East Brunswick, NJ 08816-1100
Phone: 1.844.227.6687
contact@cronuspharmausa.com