Director, Regulatory Affairs - Advertising and Promotional Compliance Job at i-

Overview

We are seeking an experienced Director of Regulatory Affairs – Advertising & Promotion to serve as a Therapeutic Area Lead and regulatory representative for U.S. promotional review. This individual will oversee compliance of promotional materials with FDA regulations, act as the primary point of contact with the FDA’s Office of Prescription Drug Promotion (OPDP), and partner closely with cross‑functional business stakeholders. While this is an individual contributor role, the Director will have oversight and final approval authority for assigned products, managing reviewers within their therapeutic area. This position offers the opportunity to lead a therapeutic area and contribute to shaping strategy, with potential to progress into a more senior leadership position in the future.

Location

Location : Boston, MA (Onsite 3 days / week - you choose what days)

Compensation

Base pay range

$225,000.00 / yr - $250,000.00 / yr

Key Responsibilities

• Serve as the Therapeutic Area Lead and primary Regulatory Affairs representative for assigned products.
• Review and approve U.S. promotional materials for compliance with FDA regulations, including OPDP requirements.
• Act as the point of contact with the FDA, managing regulatory interactions and submissions as needed.
• Partner with Marketing, Legal, Medical Affairs, and other business stakeholders to ensure compliant and effective promotional strategies.
• Lead and support the development, maintenance, and implementation of relevant SOPs.
• Provide ad / promo compliance guidance and training across the business.
• Maintain up-to-date knowledge of industry trends, evolving FDA guidance, and global promotional regulations.
• Oversee the work of promotional reviewers within your therapeutic area, ensuring quality and compliance of output.

Qualifications

Culture

Culture : Company culture values setting employees up for success and fostering collaborative, solutions-oriented working relationships.

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Details

Benefits

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