Remote Regulatory affairs Jobs • US

Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Leads or supports cross-functional trial teams, including vendors. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.

The Principal is responsible for the delivery of service offerings and ensures the delivery of regulatory and quality solutions that are best practice and innovative to enable client success through the delivery of superior service. This role involves leading the delivery of regulatory and quality solutions, directing and advising others in the development of work products, and executing the defined consulting scope of work.

The Clinical Trial Manager is a leadership role responsible for driving the successful execution of protocols or projects, including decentralized trials, from strategic planning through close out. This involves managing timelines, budget, SOPs, and regulatory requirements to operationalize trials across the organization and site network within Care Access Research.

This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences, and includes aligning DSS study teams with program- and study-level strategies. For assigned programs and studies, the role leads the DSS Study Team and represents DS as a member of the cross-functional study team. The role also utilizes operational analytics and project management tools to optimize execution of programs and studies.

The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department and manage assigned projects. He/she will also network and benchmark outside of AbbVie to provide for best practices and processes.

Caribou Biosciences is seeking a Clinical Trial Manager to join our growing Clinical Operations group, responsible for the execution and oversight of clinical trials from start-up through close-out, ensuring alignment with ICH-GCP, applicable regulations, internal SOPs, and protocols. The CTM will collaborate cross-functionally, manage vendors and sites, and contribute to high-quality clinical trial delivery.