1 of 1 Project Management Jobs in Gwynedd

Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development … global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member … of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the More ❯