Director, US Regulatory Affairs Advertising & Promotion (Finance)

Overview
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. As the internal subject matter expert on FDA advertising and promotion regulations, this role ensures compliance while enabling innovative, science-based communication that supports commercial and corporate objectives. The Director will collaborate extensively with cross-functional teams and serve as the primary liaison with the Office of Prescription Drug Promotion (OPDP) for assigned products, while also driving process improvements and supporting capability-building in promotional regulatory affairs. This position reports to the Senior Director, USRA Advertising and Promotion.
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 (e.g., ISI, Brief Summary) 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 (e.g., OPDP meetings), 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.
• Advise clinical and regulatory development teams on trial design and labeling strategies to support future promotional claims and target product profiles.
• 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.

• Perform other duties as assigned in support of departmental and company goals.

Minimum Job Requirements Qualifications

• Bachelor's degree required; advanced degree (PharmD, JD, PhD, MD, or equivalent) 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.

Competencies

• Deep knowledge of FDA regulations, policies, and guidance governing prescription drug promotion.
• Ability to interpret and apply complex regulatory standards to a variety of promotional and scientific exchange materials.
• Skilled at developing and executing regulatory strategies that align with business objectives while managing risk.
• Anticipates regulatory challenges and proactively develops solutions.
• Strong cross-functional collaboration skills with the ability to influence and align diverse stakeholders including Legal, Medical, Commercial, and Compliance.
• Builds trust and drives consensus in fast-paced, matrixed environments.
• Excellent verbal and written communication skills, including the ability to explain regulatory concepts clearly to non-experts.
• Prepares persuasive and compliant regulatory submissions and correspondence.
• Makes informed, timely, and balanced regulatory decisions based on evolving data and enforcement trends.
• Provides nuanced, risk-based assessments that help guide strategic direction without compromising compliance.
• Demonstrated leadership capabilities, including mentoring or managing team members (as applicable).
• Fosters a culture of accountability, integrity, and continuous learning.
• Comfortable working in a dynamic, changing regulatory and business environment.
• Drives process improvements, operational efficiencies, and system enhancements (e.g., Veeva PromoMats).
• Strong organizational skills and ability to manage multiple priorities and deadlines across products and teams.
• Delivers high-quality work under pressure and within tight timelines.

Other Requirements

• This position has significant decision-making authority.
• Ability and willingness to travel approximately 10% of the year.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month.

Additional InformationThe base salary range for this full-time position is $190,000 - $240,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.
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 (including pregnancy), 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. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory. If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.