Chrysoula Koukoutsis

About Chrysoula Koukoutsis

High-impact regulatory leader with nearly 30 years of pharmaceutical development experience, with over 20-year focus in regulatory and quality roles Regulatory Head leading development strategy, CMC, labeling and advertising and promotional materials teams with both pre-approval and post-approval responsibilitiesQuality Lead for multiple areas of Quality Management Systems, including CAPA Management, Production and Process Controls, Document Management and Control, Compliance, Training Business development project management and due diligence, responsible for dozens of successful multimillion dollar programs, with vast Supply Chain, Logistical and Manufacturing Operations experience Direct, hands-on experience with various dosage forms: • injectable and lyophilized products • solid oral (tablets, capsules, soft gels) • solutions and suspensions, including sterile ophthalmic and otic products • inhalation and nasal spray complex combination product systems• transdermal patches• cytotoxic and controlled class products

Experience

1. VP, Regulatory Affairs

   Thea Pharma US

   Dec 2022 — Present

Education

• McGill University

  Bachelor of Science (B.Sc.), Microbiology

  1996 — 2000

Skills

• Validation
• Change Control
• Microbiology
• Gmp
• Project Management
• Life Sciences
• Quality Assurance
• Biotechnology
• Process Improvement
• Quality System
• Regulatory Affairs
• Lifesciences
• Product Launch
• Healthcare
• 21 Cfr Part 11
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Submissions
• Cross-Functional Team Leadership
• Strategic Planning
• Capa