Vice President of Regulatory Affairs, Advertising, Promotion, Labeling

Vice President of Regulatory Affairs, Advertising, Promotion, Labeling Location: Remote with preference for Northeast Corridor (2 days per month in New Haven, CT office) About Veradermics Founded in 2019, Veradermics, Incorporated (NYSE: MANE) is a well‑funded, publicly listed company that offers the opportunity to work in a performance‑driven, highly dynamic environment. At Veradermics, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Veradermics is a dermatologist‑founded, late clinical‑stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions. Veradermics lead product candidate, VDPHL01, is an oral, non‑hormonal treatment for men and women with pattern hair loss (PHL). We are currently conducting three Phase 3 clinical trials as we work to deliver potentially transformative solutions and aspire to redefine the standard of care in dermatology. Learn more here . Position Overview The Vice President of Regulatory Affairs, Advertising, Promotion and Labeling will establish and lead Commercial Affairs and Regulatory Labeling and will serve as the company's senior‑most regulatory leader responsible for all advertising, promotional and labeling activities. This leader will develop strategy and implement systems to ensure compliance with FDA requirements for promotional materials and product labeling. The role provides strategic leadership across Commercial, Marketing, Medical Affairs, Legal, Clinical, and CMC teams, guiding risk‑based decisions and enabling compliant business growth. Strategic Responsibilities Regulatory Guidance: Interpret and apply advertising and promotion regulations in reviews. Proactively design risk mitigation that anticipates the evolving regulatory landscape and allows for aggressive yet compliant promotional campaigns. FDA Representation: Act as the primary liaison to the FDA's Office of Prescription Drug Promotion (OPDP), including leading negotiations, interpretations of complex regulations and shaping the dialogue surrounding novel promotional strategies. Integrated Commercial Strategy Partnership: Function as a commercial partner, providing consultative leadership to cross‑functional executive teams (Commercial, Medical and Legal). Ensure seamless integration between regulatory strategy and commercial objectives, ensuring launch and post‑approval materials are strategically optimized for market impact from day one. Competitive Advantage: Develop innovative promotional approaches while maintaining compliance. Support strategic positioning of drug products to capture market share effectively and ethically. Advertising & Promotion Establish and lead the Commercial Regulatory Affairs function, including policies, processes, and governance for promotional review. Establish process and governance, including implementation of software/systems, for the Promotional Review Committee (PRC) in collaboration with Medical and Legal. Provide regulatory guidance in the review of advertising and promotional materials. Provide a leadership role in collaboration with Medical and Legal on the PRC. Conduct detailed regulatory reviews of clinical evidence supporting proposed claims; ensure consistency with FDA‑approved labeling. Oversee regulatory review and approval of promotional materials across all channels (digital, print, social media, training, press releases). Serve as primary contact for FDA's OPDP, managing advisory comment requests, negotiations, and pre‑clearance of launch materials. Direct timely submission of all approved promotional materials to FDA on Form 2253. Serve as internal expert on FDA regulations, guidance and enforcement trends governing advertising and promotion of prescription drugs. Monitor regulatory developments and enforcement actions; proactively update stakeholders and guide risk mitigation strategies. Labeling Establish and lead the Regulatory Labeling function, including governance, processes, and systems for labeling development and maintenance. Oversee creation and lifecycle management of prescribing information, patient labeling, and packaging components for all products. Ensure labeling compliance with FDA requirements; manage updates driven by regulatory changes, safety signals, or new data. Partner with Clinical, Medical, and Commercial teams to align labeling strategy with product development and commercialization plans. Implement labeling change control processes and ensure timely submission of updated labeling to regulatory authorities. Develop labeling standards and templates; ensure consistency across global markets. Represent labeling function in cross‑functional teams and regulatory interactions. Leadership & Organizational Development Build a high‑performing internal and external team. Drive a culture of excellence, innovation, and accountability; reward initiative and performance. Provide strategic and operational leadership to Commercial, Medical, Legal, and Clinical teams in developing compliant promotional materials aligned with business objectives. Collaborate with Quality to establish operating procedures. Establish and manage KPIs for regulatory reviews and labeling processes; lead continuous improvement initiatives. Cross‑Functional Partnership Collaborate with Medical Affairs and Commercial leadership to bridge development and commercialization needs. Translate complex regulatory requirements into clear, actionable guidance for cross‑functional teams. Candidate Profile | Who You Are 10+ years of progressive regulatory affairs experience within biotech or pharmaceutical companies, with a significant portion in late‑stage development. Dermatology regulatory experience required, including familiarity with regulatory expectations within dermatology. Proven track record in management of Promotion Review Committees. Deep knowledge and expertise in global regulatory environment, and global promotional guidance. Ability to collaborate and influence cross‑functionally (Medical, Legal, Commercial) and drive alignment while following regulatory regulations and requirements. Experience operating in a small to mid‑size biotech environment, ideally contributing to the transition from late‑stage development to commercialization. Ability to operate as a hands‑on, standalone regulatory leader in a lean organization, balancing strategy with execution. Strong executive presence with the ability to influence cross‑functional stakeholders and serve as a trusted partner to the Commercial organization, CEO and leadership team. Location and Travel Remote with preference for Northeast Corridor (2 days per month in New Haven, CT office). Salary and Benefits Veradermics provides a comprehensive compensation package that includes a base salary, annual performance bonus eligibility, and access to the employee stock option plan. Robust benefits package, including health coverage, retirement benefit matching, dependent care FSA, and unlimited paid time off. Veradermics is an equal opportunity employer. All employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national #J-18808-Ljbffr