Andrew Elnatan
About Andrew Elnatan
Andrew Elnatan is a seasoned Vice President of Regulatory Affairs, CMC & Quality, with over 25 years of experience in the pharmaceutical industry, specializing in oncology, immunology, and hematological diseases.
Andrew Elnatan's Professional Title
Andrew Elnatan serves as the Vice President, Regulatory Affairs, CMC & Quality. He brings a wealth of experience to this role, particularly in the fields of regulatory affairs and quality management within the pharmaceutical industry. His title signifies his leadership and expertise in managing regulatory compliance and quality standards across various projects.
Andrew Elnatan's Education
Andrew Elnatan holds a Bachelor of Pharmacy degree from Victorian College. He further advanced his education by earning a Master of Pharmacy degree from Monash University. His educational background has provided him with a solid foundation in pharmaceutical sciences, complementing his extensive professional experience in the industry.
Andrew Elnatan's Career Background
With over 25 years of experience, Andrew Elnatan has built an extensive career in the pharmaceutical industry. He has held significant positions at leading companies such as Amgen, SQZ Biotechnologies Company, Celldex Therapeutics, International AIDS Vaccine Initiative, and CSL. His wide-ranging experience spans regulatory affairs, CMC, and quality management within sectors like oncology, immunology, and hematological diseases.
Regulatory Achievements of Andrew Elnatan
Andrew Elnatan has successfully coordinated regulatory submissions, negotiations, and approvals for various drugs and biologics. He has interacted with numerous global regulatory authorities including the US Food and Drug Administration, European Medicines Agency, European national agencies, China’s National Medical Products Administration Center for Drug Evaluation, Taiwan Food and Drug Administration, and Australian Therapeutics Goods Administration. His notable achievement includes coordinating a US FDA Breakthrough Therapy Designation for an oncology asset.
Andrew Elnatan's Industry Expertise
Andrew Elnatan possesses extensive experience in regulatory and CMC within the pharmaceutical sector, particularly focusing on oncology, immunology, and hematological diseases. His in-depth knowledge and expertise have been instrumental in navigating the complexities of global regulatory landscapes and ensuring the quality and compliance of pharmaceutical products.