Directs or assists staff member(s) and independently reviews and approves promotional labeling materials and communications for prescription drug and medical device products. Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. May be assigned additional responsibilities as deemed necessary.

Job Description

• Ensures promotional materials and communications are compliant with applicable laws, regulations, and company requirements. Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of Office of Prescription Drug Promotion (OPDP) correspondence and enforcement actions.
• Reviews and approves promotional materials and provides strategic guidance on promotional messaging.
• Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives.
• Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and appropriateness for the intended audience and use.
• Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.
• Responsible for final review and approval of promotional materials, sales training materials, and corporate communications.
• Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education.
• Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy.
• Monitors changes in U.S. promotional regulations and corporate policies and procedures, and incorporates those changes into departmental processes, as appropriate.
• Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT).
• Participates in launch planning and cross-functional discussions for pipeline and commercialization activities.
• Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate.
• Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.

Qualifications

Required:

• 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry
• Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities
• Experience supporting rare disease products
• Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments
• Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment
• Solid understanding of U.S. regulatory requirements
• Excellent understanding of medical concepts and terminology
• Strong understanding of FDA advertising and promotion requirements and applicable product labeling
• Fundamental understanding of the pharmaceutical industry drug development process

Preferred:

• 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities
• Experience supporting neurology or other specialty therapeutic areas preferred
• Experience interacting with OPDP in support of launch programs preferred
• Experience supporting investigational or accelerated approval products preferred
• Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders
• Able to work across multifunctional groups
• Strong written and oral communication skills
• Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat
• The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. The candidate should be comfortable operating in a fast-paced environment, managing competing priorities, and providing practical, risk-based regulatory guidance to cross-functional stakeholders.

Educational Qualifications

• Bachelor's Degree required; Advanced scientific or clinical degree (e.g., PharmD, PhD, MS) preferred

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.