Director, Regulatory Affairs Advertising and Promotion (RAAP)

Job title: Director, Regulatory Affairs Advertising and Promotion (RAAP)

About the Role The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products and therapeutic areas. Reporting to the Head of RAAP, this role guides compliant, effective communications aligned with FDA regulations, labeling, enforcement trends, internal standards, and business objectives, and leads high-profile advertising and promotion matters with a high degree of independent judgment.

What You'll Do

• Serve as the senior RAAP reviewer for assigned products, indications, disease-state communications, and external-facing materials, including complex or high-visibility initiatives; lead resolution of complex or sensitive promotional issues; provide risk-based recommendations; ensure materials remain current with approved labeling and safety updates; maintain knowledge of evolving FDA regulations and enforcement trends; communicate regulatory developments to stakeholders; support high-priority products across the lifecycle.
• Provide strategic regulatory counsel on claims development, campaign strategy, disease awareness initiatives, launch communications, scientific messaging, and other key business activities; partner with Commercial, Medical, Legal, Compliance, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, and alliance partners to shape compliant messaging; influence cross-functional decisions; advise on promotional implications of clinical data, market events, and labeling strategy.
• Represent RAAP in promotional review committees and labeling teams; guide promotional submissions and other regulatory filings; support interactions with OPDP and regulators as appropriate; interpret evolving FDA regulations and translate them into actionable regulatory strategy and business guidance; promote consistent application of regulatory standards.
• Lead or significantly influence refinement and implementation of RAAP SOPs, review standards, governance practices, and related operating procedures; support consistency in regulatory review practices across products; identify opportunities to improve review quality, efficiency, transparency, and cross-functional collaboration; provide training to internal stakeholders; mentor colleagues; support submission review activities including pre-submissions for accelerated approvals and related promotional submissions.

What We're Looking For

• Education: Bachelor's degree in scientific, healthcare, or related discipline; MS, PharmD, PhD, MD, or JD preferred.
• Experience: 10+ years in pharmaceutical/biotechnology Regulatory Affairs with direct support of U.S. advertising and promotion review; 7+ years of U.S. RA advertising and promotion review experience in oncology with product launch experience required.
• Travel: In-house office position that may require occasional travel.

Nice to Have

• Advanced degrees (MS, PharmD, PhD, MD, or JD) preferred.

Compensation & Benefits

• Not disclosed in posting.