Azurity Pharmaceuticals, Inc. is hiring: VP, Regulatory Advertising & Promotion

VP, Regulatory Advertising & Promotion (PMRC) Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late‑stage pipeline. The company’s patient‑centric products span the cardiovascular, neurology, endocrinology, gastro‑intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity’s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. This executive role provides strategic leadership and regulatory counsel in navigating the complex landscape of prescription drug advertising and promotion. The role holder will be responsible for developing and executing strategies that not only ensure stringent compliance with global health authority regulations (e.g., FDA, MHRA, OPDP) but also maximize the commercial potential and competitive positioning of Azurity’s product portfolio. Key Strategic Accountabilities Executive Regulatory Counsel & Risk Architecture: Influence and drive interpretation and application of advertising and promotion regulations. Design risk‑mitigation architectures that anticipate evolving regulatory landscapes, allowing for aggressive yet compliant promotional campaigns. Agency Negotiation & Influence (FDA/Global HAs): Act as the primary, influential, and respected liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) and other global regulatory bodies. Lead high‑stakes negotiations, drive favorable interpretations of complex regulations, and shape the dialogue surrounding novel promotional strategies. Integrated Commercial Strategy Leadership: Function as a key commercial thought partner, providing consultative leadership to cross‑functional executive teams (Medical, Legal, Marketing, Commercial). Ensure seamless integration between regulatory strategy, long‑term development plans, and enterprise‑level commercial objectives, optimizing launch materials from day one. Competitive Advantage through Compliance: Translate deep regulatory expertise into a tangible competitive advantage, developing innovative promotional approaches while maintaining ironclad compliance and positioning drug products to capture market share effectively and ethically. Spearheaded the design and implementation of a harmonized, enterprise‑wide Global PMRC framework: Standardized risk assessment and benefit‑risk evaluation processes across all product portfolios and international jurisdictions. Chair the Global Pharmacovigilance Risk Management Council (PMRC): Lead strategic initiatives to identify, assess, and mitigate emerging safety signals, enhancing patient safety and regulatory compliance worldwide. Managed regulatory engagement and submissions for complex drug safety issues: Worked with EMA, MHRA, Health Canada, and the China NMPA to ensure alignment with diverse regional requirements. Developed and executed global compliance strategies for post‑market surveillance and aggregate reporting (e.g., PBRERs): Consistently achieved a 98 % timely submission rate across FDA, EU, and other global markets. Served as the primary liaison during major regulatory inspections and audits: Demonstrated the robustness of the global PV system and secured positive inspection outcomes. Influenced global regulatory convergence: Participated in initiatives aligned with ICH guidelines and the ICMRA, shaping future regulatory standards. Qualifications and Education Requirements Bachelor of Science in a scientific discipline; master’s or advanced degree preferred. 20 + years of regulated industry experience, including regulatory review of promotional materials for prescription drug products. Proven track record in management of promotion review committees (e.g., PMRC). Deep knowledge and expertise in the global regulatory environment and promotional guidance. Ability to collaborate and influence cross‑functionally (Medical, Legal, Commercial, Marketing) while following regulatory regulations and requirements. Attention to detail, strong written and verbal communication skills. Physical & Mental Requirements Must be able to sit for long periods of time. Frequently required to stand, walk, sit, talk, and/or hear while performing the duties. May occasionally climb stairs and/or ride elevators. Occasionally lift and/or move up to 25 pounds. Must be able to manipulate keyboard, operate a telephone and hand‑held devices. Other miscellaneous job duties as required. Benefits We Offer Unlock Your Earning Potential: Competitive compensation package, including an annual bonus based on company performance. Sales – In lieu of annual bonuses, we offer an incentive compensation program that allows you to earn more. Fuel Your Success: *Sales Only* – We offer a car reimbursement program and gas card for both business and personal use. Comprehensive Health Coverage: Excellent medical, dental, vision, and prescription coverage for you and your family. Flexibility for Your Lifestyle: Hybrid work model – two days from home, three days in the office. *Excludes Sales, Manufacturing, and some Operations positions.* Invest in Your Future: 401(k) retirement savings plan with dollar‑for‑dollar match up to 5 %. Time Off That Counts: Up to 15 vacation days annually (+ rollover up to 40 hrs) and five sick/wellness days; new employees accrue vacation prorated based on start date. Meaningful Time with Your Loved Ones: Closed between Christmas and New Year’s for an extra week off. Enjoy the Holidays: 13 company holidays annually. Invest in Your Education: Tuition reimbursement for undergraduate and graduate level courses or certifications. Recognize and Be Recognized: High Five peer‑recognition platform to celebrate colleagues’ accomplishments. 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