Regulatory Affairs Coordinator

Company: TechObserver
Location: Princeton
Posted on: January 26, 2023

Job Description:

Job DescriptionResponsible for assisting Regulatory Ad/promo associates with day-to-day activities related to submissions of promotional materials to OPDP (FDA's Office of Prescription Drug Promotion).Your responsibilities will include the following major accountabilities:--- Determine relevant attributes needed for submission (e.g., previous submission sequence number, KNGL) by using SELECT database and fill out request forms for submissions.--- Timely communicate to relevant Regulatory Operations individuals regarding upcoming submissions and provide required documentation.--- File system request forms (SRFs) for biosimilar products using Sandoz's global SRF database.--- Process OPDP submissions for biosimilar products in SUBWAY database.--- Assist with filling out FDA Form 2253.--- QC submissions from ad/promo perspective and ensure that the FDA Form 2253 correctly reflects promotional pieces being submitted to OPDP.--- Enter all ad/promo submissions into regulatory SPIRIT database.Minimum requirements:--- BA/BS Degree.--- Must be organized and detail oriented.--- Prior experience with regulatory operations--- Pharmaceutical experience in related role highly preferred

Keywords: TechObserver, Trenton , Regulatory Affairs Coordinator, Other , Princeton, New Jersey