Mónica works as Advocacy and Policy Director at GSK's CMC Global Regulatory Affairs. She is a medical biologist by training and holds a MSc in Molecular Biology and a PhD in Bioscience Engineering. Monica has over 19 year's experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and QA. She has deep expertise in vaccines product development, CTAs and MAAs globally. In her current role, she is responsible for leading GSK's global and China advocacy Lifecycle Management activities. Mónica is currently member of the EFPIA CMC, Biomanufacturing and LCM teams, ERAO Variations and M4Q teams and chairs the EFPIA Annex II/Directive 2001/83, the IFPMA QMWG and the VE LCM team with focus on LCM activities globally and in China.