Senior Director, Regulatory Advertising & Promotion

PharmaEssentia; Burlington (MA); Hybrid; USD 185,000 - 240,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision coverage

Generous paid time-off

401(k) retirement plan with company %

Medical & Dependent Care FSA

Cell phone reimbursement

Employee Assistance Program

Free parking

Job summary

PharmaEssentia USA is seeking a Director of Regulatory Advertising & Promotion to lead regulatory review, governance, and compliance for promotional materials across media. You will partner with Commercial, Medical, Legal, and Regulatory teams to ensure scientific accuracy and adherence to FDA/OPDP, FTC, and PhRMA Code.

The role requires 10+ years in pharma regulatory compliance focused on advertising and a strong background in MLR/PRC governance, SOP development, and training.

Qualifications

• Bachelor’s degree in a scientific discipline, pharmacy, public health, or a related field.
• 10+ years of progressive experience in U.S. pharmaceutical/biotech compliance, regulatory affairs, or medical review focused on advertising and promotion.
• Experience leading or serving as a senior decision‑making member of MLR/PRC for promotional and non‑promotional materials.
• Deep working knowledge of FDA advertising and promotion requirements, including OPDP and Form FDA 2253 submissions.

Responsibilities

• Provide strategic leadership for regulatory review of promotional materials across media.
• Establish a risk-based framework to ensure compliance with FDA, FTC, PhRMA Code, and internal policies.
• Oversee submission of promotional materials to FDA (Form FDA 2253, OPDP).
• Lead development and governance of SOPs, workflows, and controls for review and submission of materials.
• Train cross-functional teams on FDA advertising and promotion requirements and Subpart E.
• Maintain relationships with regulatory authorities and ensure inspection readiness.

Skills

Regulatory leadership

FDA advertising

Cross-functional collaboration

Policy development

Education

Bachelor's degree (science)

Job description

PharmaEssentia USA is seeking a Director of Regulatory Advertising & Promotion to lead regulatory review, governance, and compliance for promotional materials across media. You will partner with Commercial, Medical, Legal, and Regulatory teams to ensure scientific accuracy and adherence to FDA/OPDP, FTC, and PhRMA Code.

The role requires 10+ years in pharma regulatory compliance focused on advertising and a strong background in MLR/PRC governance, SOP development, and training.