Vice President, Global Head of Regulatory Affairs
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. 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. Overview We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead global regulatory strategy and execution across a diverse and complex portfolio. This role drives regulatory success from development through post-approval, ensuring timely submissions, approvals, and global compliance.
Requirements
- MD, PhD, or PharmD preferred with 15+ years in Regulatory Affairs
- Proven success in global regulatory submissions and approvals
- Deep expertise across FDA, EMA, and international regulatory frameworks
- Strong NCE and clinical development experience
- Experience with 505(b)(2) and/or EU Hybrid pathways preferred
- Experience leading major health authority interactions (e.g., pre-NDA/BLA, EOP2)
- Strong leadership experience managing global regulatory teams
- Expertise in GxP and global compliance requirements
- Strategic thinker with strong problem-solving and execution skills
- Excellent communication and stakeholder management skills
- Experience in fast-paced or entrepreneurial environments is a plus
Responsibilities
- Lead global regulatory strategy across multiple complex programs
- Oversee regional regulatory teams and ensure high-quality compliant submissions
- Direct global submissions and approvals while managing risks
- Lead interactions and negotiations with FDA, EMA, and global regulators
- Partner cross-functionally to align regulatory and market access strategies
- Monitor regulatory trends and adapt development strategies
- Ensure global compliance and oversee vendors/CROs
- Build and lead a high-performing global RA organization
- Communicate risks and strategic insights to leadership
Benefits
- Competitive compensation package
- Annual bonus based on company performance
- Incentive compensation program (Sales Only)
- Car reimbursement program (Sales Only)
- Gas card (Sales Only)
- Medical, dental, vision, and prescription coverage
- Hybrid work model
- Retirement Savings Plan (401K) with a 5% match
- Up to 15 vacation days annually + rollover
- Five sick/wellness days
- Company closure between Christmas and New Year's
- 13 recognized holidays
- Tuition reimbursement for undergraduate and graduate level courses or certifications
- Azurity High Five peer recognition platform
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
