Regulatory CMC Director

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. What is the role?   The Director Regulatory CMC will be accountable for the planning, preparation, and filing of CMC regulatory applications, as well as overseeing health authority interactions on CMC topics, for global, late-stage investigational products including INDs, IMPDs, clinical trial applications, and marketing applications. The person will provide guidance to cross-functional teams to ensure compliance with global regulatory requirements for multiple products and to execute the product development strategies. What are the key responsibilities?   • Accountable for the strategic planning, preparation, and filing of CMC sections of regulatory submissions including INDs, IMPDs, clinical trial applications, and marketing applications. • Leads and directs interactions with global regulatory health authorities, driving regulatory strategy and ensuring timely and high-quality responses. • Provides expert direction on the global regulatory framework for biologics and medical devices, shaping innovative approaches to complex product development programs. • Leads and implements global CMC regulatory strategies, proactively identifying risks, and key issues for investigational products and communicates those to project teams and external stakeholders. • Monitor global CMC regulations and guidance to assess relevant changes and to provide strategic regulatory guidance to product development programs. • Responsible for change controls request and oversees regulatory assessment ensuring alignment with submission strategies and regulatory requirements before implementation. • Establishes, refines, and ensures adherence to internal regulatory SOPs to optimize operational efficiency and compliance. • Partners with Quality Assurance to strategically prepare for and lead pre-approval and regulatory inspections, ensuring readiness and regulatory success. • Champions a culture of continuous improvement, driving operational excellence and innovation in regulatory processes with cross-functional collaboration. What education and experience are required? • Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. • Typically requires 10 years of experience in the pharmaceutical or biotech industry. • Onsite requirements: candidates are expected to be in the office 3 days per week (either in San Mateo, California, or Raleigh, North Carolina, depending on the successful candidate). What key skills will make you great at the role?  • Experience with complex biologic/medical device combination product or surfactants is desirable. • Comprehensive knowledge of global regulatory guidelines with a demonstrated ability to apply this information to regulatory CMC strategies for novel, complex products. • Experience in major filing activities such as NDA/BLA/MAA, significant manufacturing changes, or key health authority interactions (such as EOP2 or scientific advice meetings). • Advanced strategic thinking and problem-solving skills. • Strong sense of planning and prioritization, and the ability to work with all levels of management. Why Aerogen Pharma As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralise our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. ​ We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognised and professional development is encouraged.