Vice President, Global Head of Regulatory Affairs

About the company

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.

About the role

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.

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

Qualifications

• 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

Physical & Mental Requirements

• 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

• Competitive compensation package, including an annual bonus based on company performance
• Sales Incentive compensation program (in lieu of annual bonuses) that allows earning more, even over plan
• Car reimbursement program and gas card for both business and personal use (Sales only)
• Comprehensive health coverage: medical, dental, vision, and prescription
• Hybrid work model: two days from home and three days in the office (excludes Sales, Manufacturing, and some Operations positions)
• Retirement Savings Plan (401K) with dollar-for-dollar matching up to 5%
• Up to 15 vacation days annually + rollover (up to 40 hours), plus five sick/wellness days; new employees receive prorated vacation based on start date
• Extra week off between Christmas and New Year’s
• 13 recognized holidays over the course of the year
• Tuition reimbursement for undergraduate and graduate level courses or certifications
• Azurity High Five peer recognition platform to celebrate and receive recognition for outstanding work