CRED Project Management for Regulatory Affairs Professionals

DEFINITION of a Regulatory Affairs Professional

A regulatory profess ional is responsible for keeping track of the ever- changing legislation in all the regions in which a company wishes to distribute its prod ucts, advise on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data. They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.” https://www.topra.org/TOPRA_Member/About_Us/What_is_regulatory_affairs_/TOPRA/TOPRA_Member/What_is_regulatory_affairs.aspx?h key=d6c99cd1-dcb4-4e9f-9a6a-2fed902b2b00

TOPRA webpage, downloaded 16 June 2018