The purpose of the Central Regulatory Registration (CRR) Associate role is to manage a portfolio of molecules/products for global regulatory registrations in major markets across the products’ lifecycle from candidate selection through product withdrawal. This person will have the responsibility to create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. The Associate collaborates with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guidelines. The Associate is expected to provide business process knowledge and leadership to customers to resolve publishing issues and drive on time submissions The Associate also works closely with Regulatory Associates and Regulatory Scientists to manage information from regulatory agency interactions to ensure appropriate tracking of project timelines, pending approvals, and commitments. The Associates work involves technical, cross-functional processes in an environment of critical time frames and potentially changing priorities, therefore, a strong emphasis is placed on teamwork, leadership, communication, and self-management.
Functional and Technical Expertise
Minimum Qualification Requirements:
The following skills and abilities are directly related to the essential functions of the job.