Associate Director, Regulatory Affairs Advertising and Promotion Employer Daiichi Sankyo Location Basking Ridge - NJ Start date Jul 16, 2026 View more categories View less categories Discipline Marketing , Advertising , Regulatory Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details Job Description Job Title:

Associate Director, Regulatory Affairs Advertising and Promotion Job Requisition ID:

1826

Posting Start Date:

7/16/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) 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. Reporting to the Head of RAAP, this role serves as a primary Regulatory reviewer and subject matter expert for assigned scope and helps ensure materials are developed, reviewed, and approved in accordance with FDA regulations, guidance, approved labeling, internal standards, and relevant regulatory precedent prior to dissemination. The Associate Director provides practical, risk-based regulatory guidance to cross-functional stakeholders and supports compliant, business-aligned promotional execution. This role is responsible for independent day-to-day review of assigned materials, participation in cross-functional review forums, and contribution to review practices that improve consistency, efficiency, and transparency across the RAAP function. The Associate Director applies established regulatory standards and precedent within assigned scope and escalates novel, high-risk, or precedent-setting matters to the Head of RAAP, as appropriate. Job Description 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. 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. Qualifications Education Qualifications Bachelor's Degree 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 Travel Requirements In-house office position that may require occasional travel. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range:

USD$166,720.00 - USD$250,080.00 Download Our Benefits Summary PDF Professionals Company Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com . Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com .

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4568 Company info Website http://www.daiichisankyo.com/ Phone (908) 992-6400 Location 211 Mt. Airy Road Basking Ridge New Jersey 07920 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Manager, Quality Control San Diego, CA Manager, R D Thought Leadership and Reputation Tarrytown, New York Senior Manager, Regulatory Strategic Planning - Hybrid North Chicago, IL