Head of Regulatory Advertising and Promotion

Join a Legacy of Innovation 125 Years and Counting!

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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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

Job Summary:

The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory activities related to the review, approval, and compliance of advertising and promotional materials for the company's pharmaceutical products. This leadership role is critical in ensuring that all promotional strategies align with FDA regulations, industry standards, and corporate objectives while effectively supporting commercial goals. This role also involves managing a team of regulatory professionals, fostering collaboration across departments, and maintaining a proactive approach to regulatory risk management and industry engagement. The individual will serve as the primary regulatory advisor for cross-functional teams, including marketing, medical affairs, and legal, on the product material review team (PMRT), and will act as the main point of contact with the FDA's Office of Prescription Drug Promotion (OPDP). This individual must have comprehensive knowledge of FDA regulations, including labeling requirements and promotional guidelines, as well as experience in assessing the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives. This individual will also play a pivotal role in collaborating with our alliance partners to align regulatory strategies and promotional practices.

Responsibilities

Strategic Leadership:

• Develop and implement regulatory strategies for advertising and promotional materials to ensure compliance with FDA regulations (e.g., OPDP requirements) and other applicable guidelines.
• Serve as the primary regulatory advisor to cross-functional teams, including marketing, medical affairs and legal, to align promotional strategies with regulatory requirements.
• Assess the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives. Work closely with alliance partners to align regulatory strategies and ensure consistency in promotional practices across joint initiatives. Address and resolve regulatory challenges that arise in alliance partner collaborations.

Review and Approval of Promotional Materials:

• Review and approve advertising and promotional materials for compliance with FDA regulations, industry guidelines, and company policies.
• Build strong relationships with cross-functional stakeholders. Collaborate with marketing, medical and legal teams, internally and with alliance partners, to ensure promotional content is accurate, balanced, and compliant with FDA regulations.
• Manage interactions with the FDA's OPDP, including submission of materials and addressing feedback. Review and approve regulatory submissions related to promotional materials.

Team Leadership:

• Provide leadership and vision to the regulatory advertising and promotion team, ensuring alignment with corporate goals and priorities. Lead, mentor, and develop a team of regulatory ad/promo professionals.
• Foster a culture of collaboration, innovation, and continuous improvement within the team.

Compliance and Risk Management:

• Proactively identify potential regulatory risks in advertising and promotional strategies and develop mitigation plans.
• Ensure adherence to company policies, industry standards, and FDA guidelines for promotional activities.
• Conduct risk assessments and provide actionable recommendations to mitigate compliance risks.
• Provide training and guidance to internal teams on regulatory requirements for advertising and promotion.

Regulatory Intelligence:

• Monitor changes in FDA regulations, guidance, and enforcement trends related to advertising and promotion.
• Provide insights to the organization on regulatory trends and their potential impact on promotional strategies.
• Represent Daiichi Sankyo in industry forums, conferences, and regulatory meetings to stay updated on best practices and emerging issues.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• PharmD e.g., advanced degree like PharmD, JD, master's degree required

Experience:

• 10 or More Years experience required - 15 years in the pharmaceutical industry preferred
• 10 or More Years in regulatory advertising and promotion required.

Travel:

• Ability to travel up to 20% 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:
$238,275.00 - $397,125.00

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