Director of Labeling & Promotional Review
$225,000–$260,000 year
Hybrid · Princeton, New Jersey, United States
Job Summary
Director of Regulatory Labeling, Advertising, and Promotion leads U.S. product labeling and promotional regulatory activities, overseeing core labeling documents (USPI, patient information leaflets) and lifecycle management. Partners with Supply Chain, Commercial, Medical, Legal, Compliance, and Regulatory Operations to embed regulatory compliance into labeling, marketing strategies, and execution (Regulatory Operations based in India). Designs and optimizes Medical & Legal Review processes for Promotional and Medical Affairs materials, SOPs, and Review Committee operations to strengthen compliance and efficiency. Serves as the regulatory lead on the Promotional and Medical Review Committees, manages advisory requests and 2253 filings with OPDP, and engages in enforcement risk management. Provides strategic regulatory input on claims, safety information, and labeling changes, assessing impact on promotional materials and communications strategy. Trains internal teams on FDA enforcement trends and guidance updates; maintains a robust knowledge base to balance compliance with business objectives.
Required Qualifications
- 10+ years of regulatory affairs experience in biotech or pharmaceutical industry
- at least 5 years in labeling and promotional review
- deep knowledge of FDA labeling, promotion, and related regulations
- ability to balance compliance with marketing objectives
- experience leading cross-functional promotional review committees (PRC/MRC)
- track record of translating regulatory requirements into actionable guidance
- strong collaboration and risk communication skills
- experience with FDA enforcement trends and guidance updates
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