Speaker Profile
Figen Kabadas Oge

Figen Kabadas Oge

Pharmacy and Medicine
Boulogne-sur-mer, Hauts-de-France, France

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Figen is a detail-oriented and self-motivated head of regulatory affairs with 10+ years of experience in both small and large molecule drugs. She lead the role of “Bridge builder” to keep the balance of regulatory requirements between the pharmaceutical companies and the government agencies. Her capability includes but is not limited to CMC authoring, submission dossiers preparation and strategy development for CTA/ MAA/variations, PSURs, renewals, lifecycle management, eCTD submissions, Q&A to NCA, regulatory submission dossier review and compliance (GMP Clearance, gap analysis) for EU, US, Canada and emerging markets, project & team management.
Today, She thorough knowledge and ability to build relationships based on trust, respect, and transparency in the workplace allow me to act as a coach, a mentor and a trainer to my RA team. Holding two Master’s Degrees in Technical Regulatory Affairs (CMC) and in In Silico Drug Design (France and Italy) and she speak English, French and Turkish languages.