Associate Director, Regulatory Affairs Advertising and Promotion

Job Summary

The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) at Daiichi Sankyo provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio.

Responsibilities

• Promotional Review, Regulatory Intelligence, and Regulatory Assessment
• Provide regulatory review, guidance, risk assessment, and mitigation recommendations for branded and unbranded promotional materials to ensure compliance with FDA advertising and promotion requirements, approved labeling, internal policies, and company standards.
• Review a broad range of HCP- and patient-facing promotional materials and assess them for consistency with prescribing information, fair balance, risk communication, evidentiary support, and relevant FDA/OPDP expectations.
• Apply current laws, regulations, guidances, enforcement trends, and regulatory precedent to assigned reviews and recommend practical, compliant solutions that support business objectives.
• Maintain current knowledge of evolving advertising and promotion requirements and communicate relevant regulatory developments and implications to stakeholders and colleagues.
• Strategic Regulatory Guidance and Cross-Functional Leadership
• Participate in concept-stage discussions and formal promotional review meetings to provide proactive, solution-oriented, and risk-based regulatory guidance during material development.
• Serve as the RAAP reviewer for assigned products and communications within PMRT and other cross-functional review forums.
• Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
• Build effective working relationships with stakeholders and escalate significant regulatory issues, interpretive questions, or unresolved cross-functional disagreements to RAAP leadership, as appropriate.
• Governance, Policy Interpretation, and Health Authority Support
• Serve as a RAAP reviewer in promotional review committees and as a functional representative on the Labeling Working Team for assigned products and materials, as appropriate.
• Guide and support required promotional submissions, including Form FDA 2253, Subpart E/H, advisory comment submissions, and other regulatory filing activities.
• Support ad/promo interactions with OPDP and other regulatory authorities in partnership with RAAP leadership.
• Apply current FDA regulations, guidances, enforcement trends, compliance letters, and relevant regulatory precedent to assigned reviews, and escalate ambiguous, novel, or high-risk interpretive issues as appropriate.
• Functional Support, Process Improvement, and Capability Building
• Support implementation and reinforcement of consistent RAAP review practices, workflows, decision principles, and review expectations across assigned products and materials.
• Aid in development, maintenance, and application of internal procedures, standards, guidance documents, and review tools related to promotional review.
• Support continuous improvement efforts that enhance review quality, consistency, transparency, and efficiency across the RAAP function.
• Provide training and knowledge-sharing for internal stakeholders on advertising and promotion requirements, enforcement trends, and company expectations.

Qualifications

• Education Qualifications:
• Bachelor's Degree in Scientific, healthcare, or related discipline required.
• PharmD, PhD, MS, MPH, or JD preferred.
• Experience Qualifications:
• 7+ years relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs, including direct support of U.S. advertising and promotion review preferred.
• 4+ years U.S. regulatory affairs advertising and promotion review experience in oncology with product launch experience required.