Director, Regulatory Compliance

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy. We invite you to join us.

Hybrid

Serve as a strategic partner supporting compliant, effective external communications across a growing oncology portfolio while helping strengthen and streamline Taiho Oncology’s promotional review capabilities.

• The Director, Regulatory Compliance (Promotional Review Committee) servesas a key member of the Promotional Review Committee (PRC), providing regulatory guidance and oversight for promotional, medical, and educational materials. This position partners closely with Commercial, Marketing, Medical Affairs, Legal, Compliance, and Market Access teams to ensure that external communications and promotional activities comply with applicable FDA regulations and standards, industry guidance, company policies, and approved product labeling.
• The incumbent provides strategic regulatory input throughout the development, review, approval, and lifecycle management of promotional materials and programs and supports the efficient review of a growing portfolio of promotional initiatives.

• Serve as the Regulatory Compliancerepresentativefor the Promotional Review process, including participation in PRC.
• Review promotional, non-promotional, scientific exchange, and educational materials for regulatory compliance.
• Contribute to interpretation of FDA regulations, guidance documents, enforcement trends, and industry standards related to advertising and promotion.
• Partner with Marketing, Medical Affairs, Legal, Compliance, Market Access, and Sales to facilitate compliant and effective communications.
• Advise business partners on promotional strategy, claim development, and risk mitigation.
• Support launch planning and review of promotional campaigns for new products and indications.
• Assist in preparing responses to FDA inquiries related to promotional activities.
• Monitor regulatory developments and communicate emerging requirements and enforcement trends to internal stakeholders.
• Contribute to process improvements that enhance PRC effectiveness, efficiency, and consistency.
• Provide training and education to cross-functional partners regarding promotional regulations and review requirements.
• Support audits, inspections, and compliance assessments involving advertising and promotion activities.
• Collaborate with external regulatory consultants as needed.

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Regulatory Affairs, or related discipline required.
• Advanced degree, such as PharmD, PhD, MS, MBA, or JD, preferred.

• Minimum 10 years of pharmaceutical or biotechnology industry experience.
• Significant Regulatory Affairs experience with direct responsibility for promotional review and…