Shaun Stapleton
VP, Regulatory Affairs
REGULATORY AFFAIRS PRACTICE
Shaun Stapleton is an influential senior regulatory affairs and drug development professional with extensive leadership, strategy and project management expertise in pharma, biotech and consulting environments. Shaun’s experience includes roles at Eli Lilly, Boehringer Ingelheim, Ipsen, VCLS, ReNeuron, and Amryt/Chiesi).
Shaun is a strong advocate for the critical role of regulatory affairs in drug development and commercialization and holds specific interest in developing regulatory thinking in novel areas with limited regulatory precedent.
EXPERIENCE:
- Extensive leadership, strategy and project management expertise in pharma, biotech and consulting environments
- Comprehensive experience in building global regulatory strategies and development plans for complex and novel therapies
- Track record of successful global submissions across the product lifecycle including initial submissions, line extensions, new indications and post-approval activities
EXPERTISE:
- Advanced therapies
- Orphan drugs
- Global Regulatory Strategy
- Scientific Advice/Agency meetings
- US and EU expedited programs
- Appeals
- Clinical development strategy
- Drug-device combinations
- Due diligence