Regulatory Affairs Advertising & Promotion Reviewer

Job Overview

This position involves reviewing advertising and promotional materials within the Regulatory Affairs domain for compliance in the U.S. market. The role requires significant experience and expertise ensuring alignment with FDA regulations and contributing to inter-committee reviews.

Key Responsibilities

• Conduct comprehensive evaluations of promotional materials to ensure regulatory compliance.
• Play an active role in Promotional Review Committee meetings providing expert insights.
• Support the Scientific Review Committee by reviewing materials as needed.
• Work independently with minimal oversight to manage regulatory review processes effectively.

Qualifications and Experience

• Bachelor's degree is a mandatory educational qualification.
• Possess over five years of direct experience in Regulatory Affairs advertising and promotion review.
• Have thorough knowledge of FDA advertising and promotional regulations applicable to the U.S. market.
• Demonstrated ability to strategize for promotional compliance and regulatory pathways.
• Strong verbal and written communication capabilities for clear internal and external correspondence.
• Previous experience in medical device regulatory review preferred; pharmaceutical or drug product background also considered acceptable.