Senior Director / Regulatory Affairs Head - US

About the position 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. 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. If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions. Responsibilities • Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. • Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. • Ensures compliance for global regulatory requirements. • Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors. • Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products. • Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule. • Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies. • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success. • Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks. • Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible. • Leads and manages meetings and/or interactions with regulatory authorities and agency meetings. • Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. • Monitor and anticipate trends that impact both the regulatory and access environments. Requirements • MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs. • Proven success in regulatory submissions. • FDA, US, Canada, ROW, and post-marketing experience is a plus. • Previous experience in attending and leading a team to prepare for major health authority interactions. • Experience with investigational drugs, including late stage development, and marketed products. • CRO management experience preferred. • Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable. • Must be a strong leader that creates a vision for group. • Must be strong overall and able to train/develop staff in the area of regulatory strategy. • Strategic thinker, planner, and implementer with excellent organizational skills. • Excellent oral and written communication skills. • Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables. • Demonstrates potential for a high level of collaboration with others and within global teams. • Independent thought, negotiation skills, integrity, and adaptability. • Ability to work on own and in virtual setting. • MS Office skills with excellent use of excel, PowerPoint and MS Project required. • Fluent in English (written and oral). Nice-to-haves • Recent experience with a smaller entrepreneurial environment is a definite asset. Benefits • Competitive compensation package, including an annual bonus based on company performance. • Incentive compensation program for sales roles. • Comprehensive medical, dental, vision, and prescription coverage. • Hybrid work model allowing two days from home and three days in the office. • Bagel Tuesday perk for on-site/hybrid colleagues. • Retirement Savings Plan (401K) with matching up to 5%. • Generous time off policy, offering up to 15 vacation days annually + rollover. • Company closure between Christmas and New Year's. • Recognition of 13 holidays throughout the year. • Summer-Hours perk available between Memorial Day and Labor Day. • Tuition reimbursement for undergraduate and graduate level courses or certifications. • Azurity High Five peer recognition platform. Apply tot his job