Global Head of Regulatory Affairs

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.

By joining us as the Global Head of Regulatory Affairs you will have significant responsibility and autonomy for your work and contributions. You will develop and lead global strategies to maximize global regulatory success toward achievement of program objectives for complex and multiple projects.

• Oversee regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan.
• Provide strategic and tactical advice to allow the timely and efficient conduct of all regulatory projects.
• Ensure compliance for global regulatory requirements.
• Lead cross‑functional initiatives, influencing and demonstrating leadership behaviors.
• Direct and oversee multiple projects, generally with global/regional oversight, ensuring regulatory compliance.
• Collaborate with other RA functions and vendors to ensure regulatory submissions and approvals are achieved on schedule.
• Support access functions by providing regulatory documents for value and access discussions.
• Provide leadership and development for direct reports, including regional regulatory leads.
• Communicate developments that may impact regulatory success to project teams and stakeholders.
• Anticipate risks, develop solutions, and discuss with team and management.
• Accountable for all global submissions and approvals of projects.
• Lead and manage meetings with regulatory authorities and agency meetings.
• Maintain compliance for products and oversee vendor responsibility for regulatory activities.
• Monitor and anticipate trends that impact both the regulatory and access environments.

• MD, PhD, or Pharm
  
  D in a scientific discipline preferred, with 15+ years of experience in Regulatory Affairs.
• Proven success in regulatory submissions.
• Experience with FDA, EU, Canada, ROW, and post‑marketing; sound knowledge of GxP, FDA, and EU guidelines.
• Leadership experience in preparing for major health authority interactions (e.g., FDA pre‑NDA/BLA, EOP2, advisory committees).
• Experience with investigational drugs, late‑stage development, and marketed products.
• Prior managerial experience, supervising mid‑to‑senior level regulatory professionals.
• Strong leadership, vision creation, motivation, mentorship, and training skills.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills, adept at presenting to technical and non‑technical audiences.
• Ability to plan and execute regulatory projects, delivering results within business‑defined time frames.
• Proficiency with Microsoft Office, Excel, PowerPoint, and MS Project.
• Experience in a smaller entrepreneurial environment is an asset.
• Fluent in English (written and oral).

• Must be able to sit for long periods.
• Frequent standing, walking, talking, and hearing required.
• Occasional stairs or elevator use.
• Occasional lifting of up to 25 pounds.
• Manipulation of keyboard, telephone, and hand‑held devices.
• Other miscellaneous duties as required.

• Competitive compensation package with annual bonus based on company performance.
• Car reimbursement program and gas card for business and personal use.
• Hybrid work model: two days from home, three days in office (sales and manufacturing excluded).
• Retirement Savings Plan (401(k)) with dollar‑for‑dollar matching up to 5%.
• Generous time‑off policy: up to 15 vacation days annually (prorated), 5 sick/wellness days, rollover up to 40 hours.
• Holiday schedule: 13 holidays and additional week off between Christmas and New Year’s.
• Tuition reimbursement for undergraduate and graduate level courses or certifications.
• Peer recognition platform (Azurity High Five).
• Comprehensive health coverage (medical, dental, vision, prescription).

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