Gulen is a regulatory affairs and market access expert with over 20 years of extensive experience in sterile production and ophthalmology within pharmaceutical industry. She has been involved in projects dossier submissions, market access and quality management within major pharmaceutical markets such as US, EU and UK as well as niche markets such as Turkey, Africa and Middle East. Gulen specialised in: • CMC submission strategy • Global MA & CTA submissions (UK, EU, US, Turkey and Middle East) • Team and project management • Regulatory intelligence • Lifecycle management • Establishment of quality management systems