Regulatory Jobs in 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: Director Global Regulatory Lead A leading pharmaceutical company is growing their team with a Director Global Regulatory Lead to develop and lead global regulatory strategies for complex projects. This is an exciting chance to join a leading company in the industry to support high-level strategies across the entire drug development lifecycle...

Director, Regulatory Affairs - CMC (Individual Contributor) Location: Flexible (U.S. based only, remote or hybrid options available) Employment Type: Full-timeSummary: A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regulatory CMC activities for late-stage and commercial products. This individual w...

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...

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...