Regulatory Affairs Manager

A company is looking for a Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote).

Key Responsibilities :

Guide and coordinate regulatory strategy for labeling, advertising, and promotions for product launches

Maintain oversight of promotional and labeling systems for managing review and approval processes

Organize cross-functional meetings for change controls and manage submissions to regulatory authorities

Required Qualifications :

Bachelor's degree in science with 10+ years of experience in Regulatory Affairs

Regulatory affairs certification (RAC) preferred

Experience in preparing regulatory submissions and knowledge of electronic submission processes

Strong understanding of the global pharmaceutical regulatory environment, particularly in North America

Demonstrated experience in managing change controls and promotional materials in a pharmaceutical organization