Senior Manager, Global Regulatory Affairs - Biologic-Device

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. About the role: Aerogen Pharma is building for the next phase of growth and is seeking a Senior Manager, Regulatory Affairs who can operate successfully in a fast-moving, small-company environment. This is a hands-on role for a regulatory professional who enjoys both strategy and execution. You will help shape the regulatory path for a biologic-device combination product while also driving critical day-to-day deliverables that keep clinical development moving. This is not a review-only role. You will be expected to work closely with leadership to define practical regulatory plans and then personally help deliver the documents, timelines, and cross-functional coordination needed to execute them. In this role, you will:

• Serve as the Regulatory Affairs lead for assigned programs, studies, and regulatory deliverables.
• Translate development strategy into clear, executable regulatory plans for the U.S. and ex-U.S. markets.
• Lead preparation and maintenance of INDs, CTAs, amendments, annual reports, DSURs/IB updates, orphan submissions, and meeting packages.
• Support major-filing readiness activities for BLAs, MAAs, and other regional marketing applications, including contribution to submission planning, module ownership, cross-functional content coordination, and health-authority response management.
• Represent Regulatory Affairs on cross-functional project and study teams and provide practical guidance on clinical, CMC, device, nonclinical, labeling, and lifecycle considerations.
• Coordinate preparation for health-authority meetings and interactions, including agenda development, briefing materials, response strategies, issue escalation, and commitments tracking.
• Assess regulatory risks and changes to development plans and propose mitigation strategies in collaboration with program leadership.
• Partner with Clinical Development and Pharmacovigilance to ensure global INDs/CTAs remain compliant and current, including safety-reporting and maintenance obligations.
• Partner with Technical Operations/CMC, Quality, and external partners to ensure manufacturing, analytical, and device-related regulatory inputs are submission-ready and aligned with program timelines.
• Support regulatory intelligence activities by monitoring changes in regulations, guidance, precedents, and competitive landscape where relevant, and translating those changes into clear internal recommendations.
• Support inspection readiness and quality compliance by maintaining complete, accurate, and retrievable regulatory records and by participating in SOP/process improvement activities.
• As applicable, support device constituent or combination-product documentation and regional requirements, including CE/MDR-related deliverables or equivalent device submissions where they are part of Aerogen's regulatory strategy.

You may be a strong fit if you:

• Have a bachelor's degree in life sciences, pharmacy, chemistry, biology, engineering, or a related discipline.
• Have 5+ years of regulatory affairs experience in biotech, pharma, or combination products.
• Have direct experience with global clinical development submissions, especially INDs and CTAs.
• Are experienced contributing to major filing activities such as BLA, NDA, or MAA submissions, significant manufacturing changes, or key health-authority interactions.
• Are comfortable moving between strategy discussions, technical document work, and deadline-driven coordination.
• Write clearly, organize complex information well, and follow through reliably in a matrix setting.
• Can influence cross-functional teams without relying on hierarchy.
• Bring familiarity with FDA, EMA, ICH, and eCTD workflows

Preferred but not required:

• Advanced degree and/or Regulatory Affairs Certification (RAC)
• Experience with biologics, combination products, or technically complex development programs.
• Experience supporting Pre-IND, End-of-Phase, Scientific Advice, or similar agency meetings.
• Experience with Veeva RIM, eCTD publishing workflows, and regulatory document management systems.

What success looks like :

• Assigned regulatory submissions and responses are delivered on time and to a high quality standard.
• Regulatory risks are identified early, communicated clearly, and escalated appropriately.
• Cross-functional teams receive practical, credible regulatory guidance that helps keep development programs moving.
• Submission and health-authority records remain complete, current, and inspection-ready.
• Aerogen Pharma's regulatory capabilities, templates, and processes become stronger and more scalable over time.

Why this role is attractive:

• High visibility in a lean organization
• Broad exposure across regulatory strategy and execution
• Direct impact on clinical development and registration planning
• Opportunity to grow with the programs and the company

Work model and travel:

• This role is based in Morrisville, NC (preferred) or San Mateo, CA and follows a hybrid model with an expectation of at least 3 days per week onsite.
• Travel up to 10% as needed for key meetings, partner interactions, or team events.

Equal Opportunity: Aerogen Pharma is committed to equal employment opportunity and to providing reasonable accommodations to qualified applicants and employees in accordance with applicable law. 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 centralize 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 recognized, and professional development is encouraged. #J-18808-Ljbffr JobRx, Inc.