Assist in preparing and reviewing regulatory submissions and manage transmission through FDA ESG.
Maintain submission archive, trackers, and regulatory document templates.
Collaborate with cross-functional teams on product labeling and ensure compliance.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. We are a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Lead TMF operations across clinical studies to ensure timely, complete, and inspection-ready documentation in compliance with ICH-GCP and regulatory standards.
Establish TMF governance, monitor quality metrics, and communicate findings to study teams and leadership.
Partner cross-functionally to drive process improvements and strategic oversight of CRO-managed TMF activities.
BridgeBio pioneers a 'moneyball for biotech' approach, pooling early-stage research to reduce risk and accelerate innovation for life-changing medicines. They foster a culture of curiosity and experimentation with a focus on ethics.