Aquestive Therapeutics is hiring: Director, Advertising, Promotional & Labeling

Director, Advertising, Promotional & Labeling Join to apply for the Director, Advertising, Promotional & Labeling role at Aquestive Therapeutics . Overview We are seeking a highly experienced and strategic Director of Advertising, Promotional & Labeling to lead regulatory review of promotional and labeling materials for both prescription and over-the-counter (dietary supplement) products in our growing biotech portfolio. Key Responsibilities Serve as the regulatory lead for MLR, overseeing review, approval, and triaging of promotional advertising and disease awareness materials directed to healthcare professionals, patients, consumers, and clinicians. Interpret and apply FDA regulations and industry best practices for product promotion and labeling. Collaborate cross-functionally with Commercial, Medical Affairs, Legal, and Compliance to align content with strategic messaging while mitigating regulatory risk. Provide regulatory guidance on labeling development and maintenance, ensuring compliance with FDA labeling requirements. Lead interactions with FDA regarding promotional submissions, advisory comments, and enforcement trends. Monitor evolving regulatory landscape, translate guidance into actionable insights for internal teams. Develop and deliver internal training to ensure stakeholder awareness of applicable promotional requirements. Support regulatory strategy for new product launches and lifecycle management across promotional platforms. Lead and mentor junior regulatory team members as applicable. Qualifications Bachelor’s degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, JD, or MBA) preferred. 10+ years of experience in Regulatory Affairs, including a minimum of 5 years in Advertising & Promotion review (MLR/PRC environment). In-depth knowledge of FDA regulations and OPDP standards for advertising and promotion of pharmaceuticals and over-the-counter (dietary supplements) products. In-depth knowledge of FDA labeling requirements. Proven experience as an MLR Chair or equivalent promotional review lead. Experience preparing submissions to OPDP. Excellent verbal and written communication skills with strong attention to detail. Demonstrated ability to lead cross-functional teams and manage multiple priorities in a dynamic environment. Preferred Experience Experience with 505(b)(2), allergy/immunology disease space, rare disease, or CNS promotional strategies. Experience with VEEVA PromoMats system. Experience with FDA interactions. Familiarity with international promotional and labeling requirements. Compensation Expected base salary range: $180,000 – $230,000 USD. Location Secaucus, NJ (New Jersey). Legal Disclosure Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. As part of Aquestive's employment process, final candidates will be required to complete a drug test and background check prior to employment commencing. Aquestive is a drug‑free workplace and has a drug‑free workplace policy in place. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Equal Opportunity Employer Equal Opportunity Employer Recruiting Referrals increase your chances of interviewing at Aquestive Therapeutics by 2x. #J-18808-Ljbffr