Seppe De Gelas

About

Confirmed experience with international regulatory affairs and quality assurance, mainly in pharmaceutical development and manufacturing Specialties: Quality Assurance, contact with health authorities, FDA inspections, Quality Systems, Regulatory Affairs

Experience

• VP Regulatory Affairs and Quality Assurance at Hyloris Pharmaceuticals
  Apr 2021 - Present · 5 yrs 3 mos

• Lecturer European Regulatory Affairs at University of Georgia - College of Education
  Dec 2015 - Present · 10 yrs 7 mos

  The UGA RA Programs are academic graduate programs designed to prepare Regulatory Affairs Professionals for careers in the Medical Device, Pharmaceutical, Biologics, and Animal Health business sectors. These programs are web-based and part-time programs. Course work uses a blended instructional approach of asynchronously delivered content and interactive project work taught by subject matter experts from industry, the university, and regulatory agencies to ensure that the content is current and relevant. Classes are intended to allow individual flexibility, yet are structured to progress student learning during the semester. Each semester is 15-16 weeks in length except for summer semester which is 11 weeks.

• Director Regulatory Affairs & Quality Assurance at Boletus Consulting
  Jan 2010 - Present · 16 yrs 6 mos

  Your Partner in Pharmaceutical & Biotech Quality Assurance Focused on results More than 20 years of hands-on experience

• Regulatory and Quality Affairs Director at Indigo
  Sep 2018 - Apr 2021 · 2 yrs 8 mos

• Regulatory Lead @ CMC Global Regulatory Affairs department at GSK
  Oct 2013 - Jan 2017 · 3 yrs 4 mos