Are you a Regulatory Affairs Specialist in Massachusetts looking for a new Regulatory Affairs Specialist role? Are you employed but could do with some extra cash? Would you like to work with a leading and global Biotech?
My client, A leading Biotech, the subsidiary of a top 5 Pharma are looking for a Regulatory Affairs Specialist in Massachusetts.
Experience in regulatory experience doing routine submission work – mainly NDA and IND annual reports and possibly some CMC NDA/BLA supplements.You must be familiar with preparing, reviewing, and overseeing routine electronic submissions to FDA, preparing Submission Compilation Plans and using a Documentum based document management system, FDA form and cover letter preparation, storing documents appropriately and working with a Regulatory Operations submission publishing team.
Education: Minimum college education would be a BS in Chemistry, Biology, or the Regulatory Sciences
You have taken the time to read this job ad, please apply and I will give you a call to discuss this position. Alternatively, if you're feeling brave call me on 646-415-8221 and ask for Michael Evans.