Advertising and Promotional Regulatory Reviewer

Job Title: Advertising Promotional Regulatory Reviewer

Location: Remote with expected travel to the client office in Virginia, USA (once a fortnight or as per client PRC meeting requirements)

Employment Type: Contract

Role Overview

This role is responsible for regulatory review of Advertisement and Promotional materials for Pharmaceutical products and ensures that the specified materials are compliant and aligned with the requirements of the US FDA/OPDP/APLB specific regulations, industry code of practice

standards for the US Market. The Ad Promo Regulatory Reviewer is expected to be a subject matter expert to review such materials for compliance with US FDA CFL requirements (Consistent With FDA product Labeling).

Key Responsibilities

Hands-on Experience in performing Regulatory review (MLR) of advertising and promotional materials content to ensure compliance with US FDA /OPDP/APLB specific regulations and industry code of practice standards for the US Market.

Demonstrates sound knowledge of the US FDA’s CFL requirements and hands-on experience in identifying inconsistencies in promotional materials against the US FDA’s regulatory CFL compliance of Pharmaceutical promotional communication, and demonstrates experience in providing advice on potential implications of non-compliance (OPDP enforcement).

Good understanding of the MLR review process, including content validation of scientific accuracy, claims substantiation, and clinical evidence.

Proficient in Regulatory review aspects such as fair balance, benefit-risk communications, and compliance with US FDA regulatory guidance.

Hands-on experience with lifecycle management (LCM) tools like Veeva Vault PromoMats and Vault MedComms tools.

Experience in reviewing a wide range of advertising and promotional materials, such as A/V ads, HCP presentations, podcasts, brochures, websites, FAQs, social media content, digital ads, campaign materials, press releases, and disease awareness materials.

Mandatory to demonstrate experience with performing regulatory review of advertising and promotional materials content to ensure such communications are consistent with FDA-required labeling, such as product labels, prescribing information (PI), Important Safety Information (ISI), Patient Information Leaflets (PILs).

Qualifications and Experience

6–8 years of experience.