Director, Regulatory Affairs Strategy

Job Summary The Director of Regulatory Affairs is responsible for executing the company’s regulatory strategy across the development and commercial product portfolio. This role reports to the Senior Vice President, Regulatory Affairs and serves as the main regulatory contact to project teams. The director leads the regulatory affairs function, overseeing day‑to‑day operations, managing open regulatory applications (INDs, NDAs, 505(b)(2) submissions, annual reports, amendments, clinical trial applications, supplements, expedited designations, and Pediatric Study Plans), and coordinating global health authority interactions. Responsibilities Execute the defined regulatory strategy across the product portfolio. Oversee day‑to‑day regulatory affairs operations, including submission coordination, publishing, advertising/promotional review, and process improvement initiatives. Represent Regulatory Affairs within project teams and provide guidance to R&D, Clinical, Quality, and Operations teams. Communicate regulatory risks associated with development activities and recommend mitigation strategies. Serve as the primary point of contact with FDA project managers for assigned projects. Lead the preparation of responses to U.S. and global health authorities with minimal supervision. Organize and participate in cross‑functional product team meetings. Ensure product team activities align with the defined regulatory strategy. Review technical documents for submission in new INDs and NDAs and provide guidance to development teams. Author and prepare original INDs/NDAs and amendments for regulatory submission. Manage day‑to‑day regulatory activities for assigned projects. Prepare both major and routine submissions to regulatory applications. Qualifications Bachelor’s degree in a science‑related discipline; graduate degree or RAC certification is a plus. 10 to 15 years of regulatory experience in the pharmaceutical or biotechnology sector, with extensive knowledge of drug development and all aspects of regulatory submissions. Global regulatory experience, including ICH regions and Canada, is preferred. Demonstrated leadership in previous roles and proven ability to influence executive management. Strong project management skills and a track record of meeting company‑defined timelines. Excellent knowledge of current U.S. and global regulations. Strong interpersonal and cross‑functional collaboration skills. Ability to identify key regulatory risks and deliver well‑organized, detail‑oriented solutions. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not an exhaustive list of all responsibilities, duties, and skills required. The company reserves the right to make changes to the job description as necessary. Equal Employment Opportunity Aquestive provides equal employment opportunities to all colleagues and applicants 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. #J-18808-Ljbffr