Regulatory Jobs in New York, Usa

Director, Medical WritingA leading, global biopharmaceutical company is seeking a highly skilled Director of Medical Writing. This role is pivotal in the Clinical Development function, and will lead the execution of regulatory and clinical documents. Responsibilities:Develop a range of regulatory and clinical documents, including clinical protocols...

Title: Senior Associate of Regulatory Operations/CMCSummary:A leading, global pharmaceutical client of ours is looking to hire a Senior Associate of Regulatory Operations and CMC, based out of their New Jersey office. This rapidly growing client has drug products spanning generics, branded prescriptions, and injectables. This role will specifically...

Summary:The Senior Regulatory Affairs Specialist is responsible for managing appropriate regulatory and technical information to ensure regulatory compliance and support product registrations globally. This individual must possess general knowledge of global regulatory requirements relative to regulated products and other areas of responsibility as...

Essential Functions:Product RegistrationsInteracts with internal and external customers, regulatory authorities, both domestic and international, regarding product submissions, change notifications, and where applicable inspections.Coordinates and manages the preparation and submission of regulatory document required for product registration in USA...