Job Summary

The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Reporting to the Head of RAAP, this role serves as a senior regulatory advertising and promotion subject matter expert and is accountable for guiding compliant, effective communications in alignment with FDA regulations, guidance, enforcement trends, approved labeling, internal standards, and business objectives.

The Director is responsible for leading regulatory strategy and decision-making for complex, high-risk, high-visibility, or precedent-setting advertising and promotion matters. This role serves as a senior advisor to cross-functional stakeholders, plays a significant role in labeling forums, and supports advancement of consistent review practices, operational discipline, and scalable processes within the RAAP function. The Director exercises a high degree of independent judgment and is expected to resolve complex issues with limited oversight, escalating only the most significant enterprise, policy, or reputational matters, as appropriate.

Job Description

Responsibilities

Promotional Review Leadership, Regulatory Intelligence, and Regulatory Decision-Making

• Serve as the senior RAAP reviewer for assigned products, indications, disease-state communications, and other external-facing materials, including complex or high-visibility initiatives.
• Lead resolution of complex, novel, or sensitive promotional issues, including matters involving interpretive ambiguity, or significant business impact.
• Provide clear, risk-based recommendations that appropriately balance compliance expectations with business objectives.
• Ensure promotional materials remain current with approved prescribing information, safety updates, and labeling changes.
• Maintain current knowledge of evolving FDA regulations, guidances, enforcement trends, and industry practices relevant to prescription drug advertising and promotion.
• Communicate relevant regulatory developments and practical implications to stakeholders and colleagues.
• Support high-priority or strategically important products across the lifecycle.

Strategic Regulatory Guidance and Cross-Functional Leadership

• Serve as a senior regulatory voice in cross-functional planning and issue-resolution discussions. Provide strategic regulatory counsel on claims development, campaign strategy, disease awareness initiatives, launch communications, scientific messaging, and other key business activities.
• Partner closely with Commercial, Medical, Legal, Compliance, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partner(s) to shape compliant and effective messaging strategies.
• Influence cross-functional decisions by applying deep knowledge of regulatory requirements, therapeutic context, data interpretation, and promotional precedent.
• Advise on promotional implications of clinical data, market events, and labeling strategy.

Governance, Policy Interpretation, and Health Authority Support

• Serve as a senior RAAP representative in promotional review committees (e.g. Product Material Review Team) and Labeling Working Team.
• Guide and support required promotional submissions, including Form FDA 2253, Subpart E/H, advisory comment submissions, and other regulatory filing activities, as applicable.
• Support ad/promo interactions with OPDP and other regulatory authorities, as appropriate, in partnership with RAAP leadership.
• Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
• Promote consistent application of regulatory standards across assigned products, teams, and promotional contexts.

Functional Support, Process Improvement, and Capability Building

• Lead or significantly influence refinement and implementation of RAAP SOPs, review standards, work instructions, governance practices, and related operating procedures within assigned scope and functional initiatives.
• Support consistency in regulatory review practices and decision-making across assigned products and review activities.
• Identify and implement opportunities to improve review quality, efficiency, transparency, and cross-functional collaboration.
• Provide training to internal stakeholders on advertising and promotion requirements, enforcement trends, and company expectations.
• Mentor less experienced colleagues and serve as a senior resource on complex advertising and promotion issues.
• Support submission review and approval activities, including materials associated with pre-submissions for accelerated approval products, Form FDA 2253 and related promotional submission processes.

Qualifications

Education Qualifications

• Bachelor's degree in scientific, healthcare, or related discipline required
• MS, PharmD, PhD, MD, or JD preferred
  
  

Experience Qualifications

• 10+ years of relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs, including direct support of U.S. advertising and promotion review preferred
• 7+ years of US regulatory affairs advertising and promotion review experience in oncology with product launch experience required

Travel Requirements
In-house office position that may require occasional travel.