TrentonRecruiter Since 2001
the smart solution for Trenton jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds