Drives complex FDA regulatory submissions for biologic programs from Phase 1 through marketing applications.
Builds and owns quality systems including CAPA, nonconformance reports, change control, and SOP management.
Provides regulatory guidance and coordinates risk assessments to ensure rapid product approvals.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Guide product teams through FDA regulatory pathways for Class II/III medical device software.
Develop U.S. and international submission packages and integrate technical evidence.
Collaborate with cross-functional teams to maintain compliance and respond to agency questions.
A partner company in the medical device industry seeking a regulatory affairs expert for software products. The company values collaboration across engineering, quality, and product teams to ensure compliant and defensible FDA submissions.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.