Senior Manager Regulatory Affairs

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

Key Responsibilities :

Guide and coordinate regulatory strategy for labeling, advertising, and promotional materials for product campaigns

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

Organize cross-functional meetings and oversee the preparation of regulatory documents for submissions to health authorities

Required Qualifications :

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

Hands-on experience in leading and preparing regulatory submissions

Experience in reviewing change controls and promotional materials in a pharmaceutical organization

Strong understanding of the global pharmaceutical drug development and regulatory environment

Regulatory affairs certification (RAC) preferred