Associate Director, Regulatory Affairs – Ad & Promo

Daiichi Sankyo Co.; Basking Ridge (NJ); On-site; USD 167,000 - 250,000; Full time

Job summary

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Affairs Advertising and Promotion to provide regulatory review and strategic guidance for U.S. promotional and some non-promotional communications across its portfolio.

Reporting to the Head of RAAP, this role reviews materials for FDA compliance, guides cross-functional teams, and helps ensure timely, risk-based approval in line with labeling and internal standards.

Qualifications

• Bachelor's Degree in scientific, healthcare, or related discipline required.
• PharmD, PhD, MS, MPH, or JD preferred.
• 7+ years in pharmaceutical/biotech Regulatory Affairs with direct U.S. RA advertising and promotion review experience, oncology experience preferred.

Responsibilities

• Provide regulatory review, guidance, risk assessment, and mitigation 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.
• 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 elevate significant regulatory issues, interpretive questions, or unresolved cross-functional disagreements to RAAP leadership, 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 elevate ambiguous, novel, or high-risk interpretive issues as appropriate.
• Support implementation and reinforcement of consistent RAAP review practices, workflows, decision principles, and review expectations across assigned products and materials.
• Assist 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.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory review

Education

Bachelor's Degree in science/healthcare

PharmD/PhD/MS/MPH/JD preferred

Job description

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Affairs Advertising and Promotion to provide regulatory review and strategic guidance for U.S. promotional and some non-promotional communications across its portfolio.

Reporting to the Head of RAAP, this role reviews materials for FDA compliance, guides cross-functional teams, and helps ensure timely, risk-based approval in line with labeling and internal standards.