Shionogi Inc. (U.S.) is hiring : Director, US Regulatory Affairs Advertising & Pr

Director, US Regulatory Affairs Advertising & Promotion Join to apply for the Director, US Regulatory Affairs Advertising & Promotion role at Shionogi Inc. (U.S.)

The Director, US Regulatory Advertising and Promotion is a senior individual contributor responsible for regulatory strategy related to promotional and scientific exchange materials across assigned portfolios or therapeutic areas, spanning all stages of the product lifecycle.

Responsibilities

Serve as the primary Regulatory lead on Promotional and Medical Review Committees to support portfolio- or therapeutic-area level scope, providing oversight across multiple products, including pipeline assets and launch brands.

Ensure promotional and scientific exchange materials comply with FDA regulations and align with strategic brand objectives.

Provide regulatory guidance on claims, messaging, and safety information to support compliant and compelling communication.

Advance the Ad Promo function by applying best practices, mentoring staff, and driving process improvements in alignment with the Senior Director’s vision.

Lead the preparation and submission of advisory requests and 2253 filings.

Monitor FDA enforcement actions and regulatory trends to proactively inform risk assessments and strategic decision-making.

Engage in strategic, proactive liaison activities with FDA, including enforcement risk management and interpretation of evolving guidance for assigned products.

Partner with Commercial, Medical, Legal, Compliance, Regulatory Operations, and other stakeholders to ensure timely and effective material review and approval.

Assess the impact of proposed labeling changes on promotional materials and overall communication strategy.

Provide direct functional leadership within cross-functional teams, ensuring alignment across internal and external stakeholders.

Educate internal teams on the evolving regulatory landscape for advertising and promotion, including FDA guidance, enforcement actions, and industry best practices.

Provide clear, balanced, and risk-based regulatory assessments for proposed communication tactics and materials.

Drive enterprise-wide policies, training programs, and foster a strong regulatory culture focused on compliance and innovation.

Contribute to the development, refinement, and implementation of SOPs, working instructions, and best practices to ensure consistency and efficiency in promotional review.

Support continuous improvement initiatives, including enhancements to systems such as Veeva PromoMats.

Qualifications

Bachelor’s degree required; advanced degree strongly preferred.

Minimum of 8 years of regulatory experience in pharmaceutical, biotech, or related industry, with 5 years focused on advertising and promotion.

Deep understanding of FDA regulations, guidance documents, and enforcement practices related to prescription drug promotion.

Proven ability to work cross-functionally, manage complex review processes, and influence stakeholders at all levels.

Experience with regulatory systems such as Veeva PromoMats and document management tools.

Excellent written and verbal communication skills, including the ability to articulate regulatory positions clearly and persuasively.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

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