Director, Regulatory Compliance

Taiho Oncology•Princeton, NJ

2d•Hybrid

About The Position

The Director, Regulatory Compliance (Promotional Review Committee) serves as 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.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Regulatory Affairs, or related discipline required.
Minimum 10 years of pharmaceutical or biotechnology industry experience.
Significant Regulatory Affairs experience with direct responsibility for promotional review and advertising and promotion compliance.
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.
Strong knowledge of FDA regulations governing pharmaceutical advertising and promotion, including OPDP requirements, promotional guidance documents, and enforcement actions.
Ability to interpret complex regulatory requirements and provide practical business guidance.
Excellent communication, influencing, relationship-building, analytical, and risk-assessment skills.
Ability to balance regulatory compliance with business objectives and work effectively in a fast-paced, matrixed environment.
Excellent project management and organizational skills.
Proficiency in promotional review systems and workflows.

Nice To Haves

Advanced degree, such as PharmD, PhD, MS, MBA, or JD, preferred.
Oncology experience strongly preferred.
Experience supporting multiple oncology brands, specialty pharmaceutical products, digital and social media materials, market access, patient support programs, product launches, or lifecycle management initiatives preferred.

Responsibilities

Serve as the 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.