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. This involves proactively designing 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. This encompasses leading high-stakes negotiations, driving favorable interpretations of complex regulations, and shaping 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). The VP ensures seamless integration between regulatory strategy, long-term development plans, and enterprise-level commercial objectives, ensuring launch materials are strategically optimized for market impact from day one.
- Competitive Advantage through Compliance: Translate deep regulatory expertise into a tangible competitive advantage. This involves developing innovative promotional approaches while maintaining ironclad compliance, strategically positioning drug products to capture market share effectively and ethically.
Principle Responsibilities:
- Spearheaded the design and implementation of a harmonized, enterprise-wide Global PMRC framework, standardizing risk assessment and benefit-risk evaluation processes across all product portfolios and international jurisdictions.
- Chair the Global Pharmacovigilance Risk Management Council (PMRC), leading strategic initiatives to identify, assess, and mitigate emerging safety signals, resulting in enhanced patient safety and regulatory compliance worldwide.
- Managed regulatory engagement and submissions for complex drug safety issues with a wide array of international health authorities, including the EMA, MHRA, Health Canada, and the China National Medical Products Administration (NMPA), ensuring alignment with diverse regional requirements.
- Develop and execute global compliance strategies for post-market surveillance and aggregate reporting (e.g., PBRERs), consistently achieving a 98% timely submission rate across FDA, EU, and other global markets.
- Serve as the primary liaison during major regulatory inspections and audits (e.g., EMA, MHRA), successfully demonstrating the robustness and effectiveness of the global PV system and ensuring positive inspection outcomes.
- Influence global regulatory convergence by participating in initiatives aligned with ICH guidelines and the International Coalition of Medicines Regulatory Authorities (ICMRA) objectives, helping to shape 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 global regulatory environment, and global promotional guidance.
- Ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Marketing) and drive alignment while following regulatory regulations and requirements.
- Attention to detail, strong written and verbal communication skills.
#LI-Hybrid
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee 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: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
- Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
- Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
- Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
- Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
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