Azurity Pharmaceuticals - US
Vice President, Global Head of Regulatory Affairs
Woburn, MA · Exec · Full-time
Sponsorship not specifiedDetected 22 days ago
ComplianceStakeholder ManagementFDA RegulatoryLeadershipCommunicationProblem SolvingGxPRegulatory Affairs
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
- Lead interactions and negotiations with FDA, EMA, and global regulators
- Partner cross-functionally to align regulatory and market access strategies
- Build and lead a high-performing global RA organization
- Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
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
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Other miscellaneous job duties as required
- 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.
- 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
Nice to have
- MD, PhD, or PharmD preferred with 15+ years in Regulatory Affairs
Compensation
- 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.
Apply directly at Azurity Pharmaceuticals - US →Create a free account for alerts like thisView Azurity Pharmaceuticals - US immigration profile
This listing is sourced directly from Azurity Pharmaceuticals - US's careers page and normalized into a canonical job model.