Emma Williams is a seasoned Regulatory Affairs executive with a rich background spanning over two decades of global and affiliate regulatory experience. Her proficiency lies in strategic planning, as evidenced by a successful history of accelerating New Active Substance development, steering Marketing Authorisation approvals, optimising portfolio management, and implementing organisational efficiencies.
In her current role, Emma plays a crucial part in delivering European and global regulatory development, life cycle management, and strategic support to a diverse clientele. This involves managing Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), Agency meetings, orphan and paediatric applications, and Marketing Authorisation Application (MAA) submissions.
Emma’s leadership experience is underscored by her prior position as the head of the regulatory affairs team at bio CSL Australia (CSL Seqirus), where she focused on the influenza vaccine. Additionally, she spearheaded the establishment and development of a newly formed global team comprising regulatory operations and labelling professionals.
Her extensive regulatory career includes a tenure at Pfizer Consumer Healthcare, where she led the UK/Ireland Team, overseeing areas such as medicines, medical devices, food supplements, and cosmetics. Furthermore, Emma held significant Global and European regulatory lead positions at Norgine and Bristol Myers Squibb.
Emma Williams earned a Bachelor of Science degree in Biology from the University of York.