Associate Director, Regulatory Compliance

Position Summary

The Associate 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.

Performance Objectives

• 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.

Education/Certification Requirements

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.

Knowledge, Skills, and Abilities

• Minimum 5 years' experience within Regulatory Affairs, including a minimum of 3 years of experience in Advertising and Promotion.
• 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.
• Strong knowledge of FDA regulations governing pharmaceutical advertising and promotion, including OPDP requirements, promotional guidance documents, and enforcement actions.
• Experience interacting with FDA's Office of Prescription Drug Promotion (OPDP), including submissions, advisory comment requests, or responses to promotional inquiries, and/or experience supporting regulatory strategy for product launches strongly preferred.
• Understanding of pharmaceutical product development, clinical development, and labeling processes and their relationship to U.S. promotional claims and communications.
• Ability to interpret complex regulatory requirements and provide practical business guidance.
• Excellent communication, negotiation, influencing, relationship-building, strategic thinking, 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, with strong attention to detail and the ability to manage multiple priorities simultaneously.
• Proficiency in promotional review systems and workflows.
• 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.