Regulatory Affairs and Quality Assurance

The Regulatory Affairs and Quality Assurance team at PTC Therapeutics ensures that the company complies with all regulatory requirements throughout the drug development process. They oversee quality assurance for Good Manufacturing Practices (GMP) and Good Clinical Practices (GXP), manage pharmacovigilance and risk assessment, and lead the strategic development of regulatory submissions. This team plays a crucial role in safeguarding patient safety while facilitating the successful commercialization of innovative therapies for rare diseases.