Assoc Director, Regulatory Affairs - Advertising and Promotion

Associate Director - Promotional Regulatory Affairs Responsible for the review and approval of all U.S. promotional materials as the promotional regulatory expert, ensuring compliance with regulatory guidelines, company policies, and business objectives. Serves as liaison with FDA’s OPDP/APLB divisions, providing strategic regulatory input on promotional concepts, marketing strategies, and product labeling. Provides regulatory consultation to U.S. commercial teams and participates in strategy discussions and regulatory meetings. Key Responsibilities Review, approve, and provide regulatory guidance on U.S. promotional materials. Act as the primary regulatory reviewer for advertising and promotional content. Manage correspondence with FDA’s promotional review divisions (OPDP/APLB), including submission of complex regulatory questions and advisory comment. Develop and propose effective, compliant regulatory strategies and solutions to support marketing objectives while minimizing regulatory risk. Participate in labeling and global regulatory team meetings to align promotional messaging with clinical trial design, product labeling, and future promotion plans. Maintain up-to-date knowledge of FDA guidance, enforcement letters, and evolving policy issues, clearly articulating regulatory rationale. Provide training and coaching to team members on promotional regulatory matters. Contribute to the development of departmental strategic initiatives for effective regulatory review processes. Qualifications & Experience B.A. or B.S. degree in science, health care, or related fields. Master’s, Ph.D., or PharmD preferably, with emphasis in science, health care, or related fields. Minimum five years of experience in the pharmaceutical/biologics industry, with emphasis on regulatory or scientific disciplines. Minimum two years of direct experience as the primary regulatory reviewer of advertising and promotional materials. Demonstrated knowledge of FDA regulations related to advertising and promotion of prescription products. Proactive cross-functional collaboration skills and a history of successful interactions with FDA promotional review divisions. Strong communication skills, attention to detail, and ability to manage multiple priorities simultaneously. Strategic and analytical thinking, negotiation, and influence skills. Required Skills Clinical Trials cross-functional Teamwork Data Analysis Electronic Common Technical Document (eCTD) FDA Regulations Negotiation Pharmaceutical Industry Promotional Review Regulatory Compliance Regulatory Labeling Regulatory Strategies Regulatory Submissions Stakeholder Management Strategic Thinking US Regulatory Affairs Compensation Salary range: $129,000 - $203,100 per year. Eligible for annual bonus and long-term incentive plans, if applicable. Additional benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr