Senior Director, Global Regulatory Affairs

About Aerogen Pharma:

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.

We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.

Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

Join us as we embark on this breakthrough and become inspired to deliver.

Aerogen Pharma is seeking an experienced global regulatory leader to serve as the strategic deputy to the Senior Vice President of Regulatory Affairs and assume direct accountability for some of the company's priority development programs. The successful candidate will be the accountable regulatory leader for programs, shape company-level development decisions, and help build Aerogen Pharma's future regulatory organization.

The position offers unusual breadth and visibility:

• Lead US, EU, China, and rest-of-world registration strategy for a late-stage drug-device combination product.
• Build an innovative regulatory strategy for an early-stage medicine intended for low- and middle-income countries.
• Work directly with the SVP of Regulatory Affairs, executive leadership, development teams, and external business partners.
• Influence clinical development, global access, commercialization, and portfolio strategy.
• Serve as the primary regulatory decision-maker for assigned programs.
• Help establish the capabilities, operating model, and future structure of Aerogen Pharma's regulatory organization.

The role is designed for a regulatory leader who wants meaningful product ownership, broad organizational influence, and a credible path to expanded executive leadership.

• Serve as the accountable global regulatory leader for multiple development programs.
• Act as a strategic deputy and trusted advisor to the Senior Vice President of Regulatory Affairs.
• Represent Regulatory Affairs on cross-functional development, governance, and portfolio teams.
• Translate corporate and product-development objectives into integrated global regulatory strategies, plans, timelines, and resource requirements.
• Identify regulatory risks, opportunities, and critical decision points early and develop practical mitigation and contingency plans.
• Manage regulatory consultants, vendors, regional representatives, and business partners.
• Mentor regulatory team members and help build the future regulatory organization.
• Establish fit-for-purpose regulatory processes, governance practices, and operating standards appropriate for a growing pharmaceutical company.
• Promote a culture of accountability, transparency, constructive challenge, and regulatory excellence.

• Lead and execute global regulatory strategy for a late-stage drug-device combination product.
• Develop and execute the strategy for marketing authorization in the European Union and additional rest-of-world markets.
• Integrate medicinal-product, device, combination-product, human-factors, usability, manufacturing, labeling, and quality requirements into a unified regulatory strategy.
• Lead interactions with the European Medicines Agency, national competent authorities, notified bodies, and other relevant regulatory organizations.
• Assess the impact of regulatory developments on Aerogen Pharma's programs, timelines, and business strategy.
• Develop the regulatory strategy for approval in China in collaboration with Aerogen Pharma's business partner.
• Lead the preparation for and attendance at regulatory authority meetings including responses to questions.
• Support regulatory inspections, approval readiness, and launch preparation.
• Support global lifecycle-management planning, including indication…