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 products.

At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.

We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development.   Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.

Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries.

What is the role? 
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. 

What are the key responsibilities? 
Regulatory and Organizational 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. 

Late-Stage Drug-Device Combination Product 
• 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 expansion, labeling changes, device modifications, and post-approval obligations. 

Global-Access Drug Development Program 
• Lead global regulatory strategy for an early-stage drug product intended for low- and middle-income countries. 
• Build an integrated regulatory roadmap that advances global-access objectives. 
• Engage with regulatory authorities, global health organizations, development partners, foundations, and other external stakeholders. 

What education and experience are required? 
• Bachelor’s degree in a scientific, medical, engineering, or related discipline. 
• Advanced degree such as an MS, PharmD, PhD, MD, or equivalent is preferred. 
• 10 or more years of progressively responsible regulatory affairs experience in the pharmaceutical, biotechnology, or combination-product industry. 
• Demonstrated experience independently leading global regulatory strategy for a development-stage product. 
• Experience leading or making a significant contribution to a major marketing application, such as an MAA, NDA, BLA, or equivalent submission. 

What key skills will make you great at the role? 
• Demonstrated ability to lead complex cross-functional initiatives in a matrixed organization. 
• Strong strategic judgment and the ability to provide clear, independent recommendations to senior leaders. 
• Excellent written, verbal, and executive communication skills. 
• Ability to operate effectively in a small, fast-paced company and move comfortably between high-level strategy and hands-on execution. 

Why Join Aerogen Pharma 
This role provides the opportunity to shape the global development and approval strategy for multiple differentiated programs with the potential to meaningfully improve patient outcomes. The successful candidate will have direct access to executive leadership, substantial authority over assigned programs, and a central role in building Aerogen Pharma’s future regulatory capabilities. 
The position combines the challenge of preparing a late-stage drug-device combination product for global commercialization with the opportunity to create an innovative regulatory pathway intended to bring an important medicine first to patients in low- and middle-income countries. 
For the right individual, this is a career-defining opportunity to assume broad product ownership, influence enterprise strategy, and grow into expanded regulatory leadership. 

Location and Relocation 
This position is based in Research Triangle Park, North Carolina, with a flexible hybrid work model requiring on site presence at least 3 days/week. Relocation assistance available as necessary. 

Equal Employment Opportunity 
Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.