Director, Oncology Regulatory Compliance & PRC

Taiho Oncology, Inc.; Princeton (NJ); Hybrid; USD 218,000 - 256,000; Full time

Benefits offered by this job

401(k)

Paid time off

Job summary

Taiho Oncology, Inc. in Princeton, New Jersey, seeks a Director Regulatory Compliance (Promotional Review Committee) to provide regulatory guidance for promotional, medical, and educational materials, partnering with Commercial, Marketing, Medical Affairs, Legal, Compliance, and Market Access to ensure FDA and labeling compliance.

The role oversees development, review, and lifecycle management of promotional materials, supports efficient review of a growing portfolio, and helps train

Qualifications

• Minimum 10 years of pharmaceutical or biotechnology industry experience.
• Significant Regulatory Affairs experience with direct responsibility for promotional review and advertising and promotion compliance.
• Oncology experience strongly preferred.
• Demonstrated participation in a Promotional Review Committee, Medical Legal Regulatory review committee, or similar review process.
• Experience working with commercial organizations and cross-functional teams supporting marketed products.

Responsibilities

• Serve as Regulatory Compliance representative for 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.

Skills

Regulatory affairs

Promotional review

FDA regulations

Oncology

Cross-functional

Project management

Communication

Risk assessment

Education

Bachelor's in Life Sciences

Advanced degree preferred

Job description

Taiho Oncology, Inc. in Princeton, New Jersey, seeks a Director Regulatory Compliance (Promotional Review Committee) to provide regulatory guidance for promotional, medical, and educational materials, partnering with Commercial, Marketing, Medical Affairs, Legal, Compliance, and Market Access to ensure FDA and labeling compliance.

The role oversees development, review, and lifecycle management of promotional materials, supports efficient review of a growing portfolio, and helps train