Senior Director, Regulatory Affairs Advertising, Promotion and Labeling

Apnimed is a rapidly growing pharmaceutical company focused on transforming the treatment of sleep apnea through innovative, patient-friendly therapies. Our approach is rooted in a simple idea: patients with obstructive sleep apnea may benefit from a safe, effective oral medication taken once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to help maintain an open airway during sleep. Based in Cambridge, Massachusetts, Apnimed is advancing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders through cutting‑edge science and a commitment to innovation. Recognized by the Boston Business Journal as one of the Best Places to Work in both 2024 and 2025, we are continuing to grow and build the foundational operations that enable our employees, and our mission, to thrive. Position Summary We are seeking an experienced and strategic Senior Director of Regulatory Affairs Advertising/Promotion to lead FDA‑focused promotional regulatory strategy for a fast‑paced pharmaceutical startup environment. This position reports to the Chief Regulatory and Safety Officer. This individual will serve as the regulatory lead for all U.S. advertising and promotional activities, ensuring compliance with FDA regulations, OPDP expectations, and corporate standards while enabling innovative commercial execution. Ideally, the Senior Director will also collaborate with cross‑functional partners, stakeholders, and teams and lead labeling activities. The Senior Director will partner closely with Executive Leadership, Commercial, Medical Affairs, and Compliance teams to support product launch readiness and lifecycle promotional strategy. The ideal candidate brings deep expertise in FDA advertising/promotion, and labeling regulations, strong risk‑based decision‑making skills, and the ability to partner with internal stakeholders to build scalable promotional review processes within a growing organization. This is an opportunity to shape the regulatory advertising and promotion framework of a growing pharmaceutical startup at a critical stage of commercialization. You will play a highly visible leadership role with direct impact on corporate strategy, product launch success, and organizational growth. Key Responsibilities Lead the U.S. Regulatory Advertising/Promotion and Labeling functions as we prepare for our first product launch. Serve as the primary regulatory advisor for FDA/OPDP‑related promotional strategy and risk assessment. As part of the MLR team, review and approve: Unbranded/disease state materials, Consumer and HCP promotional materials, Digital and social media campaigns, Product websites and branded content, and Speaker bureau and congress materials. Ensure promotional communications are: Accurate and scientifically substantiated, Balanced with appropriate risk disclosures, Consistent with approved prescribing information and FDA guidance. Provide strategic guidance during commercial launch planning, including claims development, competitive positioning, and promotional risk mitigation. Lead interactions related to FDA OPDP inquiries, enforcement communications, and internal remediation activities if required. Contribute to development of promotional review SOPs, governance models, and training programs suitable for a startup environment. Monitor evolving FDA regulations, enforcement trends, and OPDP policy developments and communicate impact assessments. Manage label negotiations and updates during NDA review and throughout product lifecycle. Partner with Compliance to establish a proactive risk‑management culture while maintaining business agility. This is an opportunity to shape the regulatory advertising, promotion, and labeling framework of a growing pharmaceutical startup at a critical stage of commercialization. You will play a highly visible leadership role with direct impact on corporate strategy, product launch success, and organizational growth. Qualifications Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related scientific discipline required. Advanced degree preferred (PharmD, PhD, MS, MPH, or JD). 10+ years of Regulatory Affairs experience within the pharmaceutical or biotech industry. Significant expertise in FDA Advertising & Promotion & Labeling and OPDP regulations required. 5+ years’ experience in labeling in biotech/pharma preferred. Prior leadership experience supporting commercial launch. Experience operating in a startup. Strong understanding of: FDA regulations governing prescription drug promotion, OPDP enforcement practices, FDA labeling regulations, and PhRMA Code and industry compliance standards. Demonstrated success influencing senior leadership and cross‑functional stakeholders. Excellent communication, negotiation, and executive presentation skills. Ability to balance regulatory risk with commercial objectives in a dynamic environment. Preferred Experience Direct experience leading a product launch is strongly preferred. Experience supporting sleep related companies is preferred. Direct experience responding to OPDP advisory comments. Experience establishing PRC infrastructure, SOPs, and governance processes. Strategic regulatory leadership. Executive influence and decision‑making. Risk assessment and mitigation. Cross‑functional collaboration. Team development and mentorship. Operational scalability and process building. Commercial and scientific acumen. The anticipated salary range for this position is $235,000 - $260,000. The final compensation package will be determined based on an individualized assessment of the selected candidate. Candidates may be considered for compensation outside of the posted range. #J-18808-Ljbffr Apnimed