Vice President, Global Head of Regulatory Affairs

Overview

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company focused on innovative products that address the needs of underserved patients. The company leverages its integrated capabilities and extensive partner network to expand its product portfolio and pipeline, which includes cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan market products.

Key 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 Regulatory Affairs 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

Benefits

• Unlock Your Earning Potential: Competitive compensation package including annual bonus based on company performance
• Sales - In lieu of annual bonuses, incentive compensation program that allows you to earn more - even over plan
• Fuel Your Success: Car reimbursement program and gas card for both business and personal use
• Comprehensive Health Coverage: Medical, dental, vision, and prescription coverage
• Flexibility for Your Lifestyle: Hybrid work model allowing two days from home and three days in the office
• Invest in Your Future: Retirement Savings Plan (401K) matching up to 5%
• Time Off That Counts: Up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days
• Meaningful Time with Your Loved Ones: Extra week off between Christmas and New Year’s
• Enjoy the Holidays: 13 holidays recognized throughout the year
• Invest in Your Education: Tuition reimbursement for undergraduate and graduate level courses or certifications
• Recognize and Be Recognized: Azurity High Five peer recognition platform