OVERVIEW
FOCUS AREAS
More than 20 years global regulatory affairs experience
Global Regulatory Strategy
Clinical Development Advice
Agency Meetings
Due Diligence
EU Regulatory Procedures
Clinical Trial Applications/INDs
Emma Williams brings over 20 years of extensive regulatory experience to her role at ELIQUENT Life Sciences.
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.
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Bachelor of Science degree in Biology, University of York
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PROFESSIONAL EXPERIENCE
Seqirus Limited Senior Director Regulatory Affairs
BioCSL Pty Ltd Head of Regulatory Affairs
Pfizer Consumer Healthcare
Norgine
Bristol Myers Squibb Medical Imaging
EXPERTISE
Strategic and operational regulatory support to early and late phase development programmes
Full product life cycle regulatory support across small and large molecules, OTC and radiopharmaceuticals
Coordinated pre-IND and European regulatory agency meetings
Leadership
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