Shaun Stapleton

Regulatory Affairs Practice – Europe

OVERVIEW

FOCUS AREAS

Over 30 years of project management and global leadership positions in regulatory affairs in the life science industry

Advanced Therapies

Orphan Drugs

Drug development

Global regulatory strategy

As VP Regulatory Affairs within Eliquent’s Regulatory practice, Shaun provides regulatory affairs advice to clients seeking effective regulatory strategies for the global development and registration of their products, with a particular focus on novel treatments such as cell and gene therapies and on orphan drugs.

Shaun is a senior regulatory affairs and drug development professional with expertise in a range of product types, including new chemical entities, advanced therapies (cell and gene therapy), biologics, small molecules, orphan drugs and drug-device combinations. He has extensive leadership, strategy and project management expertise in pharma, biotech and consulting environments and has a particular interest in developing regulatory thinking in novel areas with limited regulatory precedent. Shaun is a strong advocate for the critical role of regulatory affairs in drug development and commercialisation with experience in applying expedited programmes and regulatory flexibilities to facilitate the development and approval of new drugs.

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