Regulatory Affairs Manager

A company is looking for a Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus).

Key Responsibilities

Conduct regulatory reviews of healthcare provider education materials for compliance with labeling and substantiation standards

Prepare and export Form FDA 2253 packages for submission to the FDA and support Regulatory Operations

Collaborate with cross-functional teams to align on promotional content and provide guidance to streamline development processes

Required Qualifications

Bachelor's degree in a scientific, healthcare, communications, or regulatory discipline preferred; advanced degree desirable

1-2 years of advertising and promotional regulatory review experience in pharma / biotech required

Working knowledge of CBER / APLB requirements for promotional materials

Familiarity with Veeva PromoMats and proficiency in MS Office 365 and Adobe Acrobat

Ability to travel approximately 10%-20%