Manager, Postmarketing Regulatory Affairs

Manager, Postmarketing Regulatory AffairsRegulatory AffairsJersey City, NJSummaryThe incumbent will be responsible for, but not limited to, providing regulatory input into strategic marketing initiatives and Forest policies regarding advertising and promotional activitiesDuties and Responsibilities-Reviewing and approval of all advertising and promotional materials for assigned products to insure that they comply with FDA regulations -Developing, implementing and maintaining regulatory procedures regarding review of advertising and promotional materials for marketed products -Act as regulatory liaison with co-promote partners regarding promotional review -Act as DDMAC liaison for assigned marketed products to facilitate FDA review -Oversee overall regulatory labeling for marketed products -Coordinate with package engineering group for labeling review and approval -Create and maintain all labeling files, including labeling history, current labeling, and change control -Assuring utilization of most current labeling in marketing materials RequirementsEducation: -BS degree in Life Sciences Experience: -Five years pharmaceutical regulatory experience -At least 2 years experience reviewing advertising and promotional materials for prescription drugs -2 to 5 years of USA prescription drug labeling experience, including FDA labeling negotiations and Core Data Sheets (as they translate to local labeling) -Knowledge of FDA regulations and guidance documents regarding advertising/promotion and labeling requirements -Good knowledge of MS Office applications (MS Word, Excel and PowerPoint) -Must be very detail-oriented -Must be able to work in a team environment -Must be able to function under tight timelines If you are interested in this position, please apply directly at: http://www.frx.com/careers/job_description.aspx?number=90880or review all of our open positions at www.frx.com/careers