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.
Manage regulatory submission planning, publishing, and lifecycle management for clinical programs.
Serve as SME for eCTD structure, validation, and document management technologies.
Drive process improvements and ensure compliance with Health Authority requirements.
Exelixis is a biotech company dedicated to discovering and developing innovative medicines for difficult-to-treat cancers. With over 25 years of experience, they foster a collaborative and inclusive culture focused on making a difference for patients.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.