Starting in 1985, she held various positions in the pharmaceutical sector.[4] From 1992 to 1995 and from 1996 to 1998 she worked for the lobbying organisation European Federation of Pharmaceutical Industries and Associations (EFPIA)[a] as Manager of Scientific and Regulatory Affairs.[5][4][6] She was Principal Administrator in the Pharmaceuticals Unit of the European Commission between 1998 and 2002, with responsibility for inspections, international activities and legislative initiatives. Ms Cooke joined EMA on 1 July 2002 where she worked first as Head of Inspections and then as Head of International Affairs.[4] From 2021 she was appointed as Head of Regulation of Medicines and other Health Technologies with the World Health Organization (WHO).[3]
In November 2020 Cooke was appointed Executive Director of the EMA,[1] also taking the position of chairperson at the International Coalition of Medicines Regulatory Authorities (ICMRA) at the same time.[2] This was in the context of the midst of the COVID-19 pandemic.
On 16 March 2021, Cooke led an EMA press conference to inform about the ongoing investigation into reports of side-effects related to the Oxford–AstraZeneca COVID-19 vaccine. Cooke said the EMA remains "firmly convinced" that the vaccine benefits outweigh the risks of potential side effects.[7][8]
Cooke's appointment was criticized in a session of the Austrian Parliament on 1 April 2021 when member of parliament Gerald Hauser claimed a potential conflict of interest between her allowing the vaccine in her regulatory function, while having worked for the very same industry as a lobbyist in the past.[9][10]
