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!
|