Mitchell Green

Mitchell Green

Associate Regulatory Affairs Manager @ BeiGene

About Mitchell Green

Mitchell Green is an Associate Regulatory Affairs Manager at BeiGene with extensive experience in regulatory affairs and pharmacovigilance across various pharmaceutical companies in Australia.

Current Role at BeiGene

Mitchell Green currently serves as an Associate Regulatory Affairs Manager at BeiGene. In this role, he is involved in regulatory submissions for oncology products. Additionally, he collaborates with cross-functional teams to support regulatory strategies and submissions, ensuring compliance with industry standards. His responsibilities include the preparation and submission of regulatory dossiers to health authorities, highlighting his expertise in regulatory processes and documentation.

Previous Experience at Bristol Myers Squibb

Mitchell Green worked at Bristol Myers Squibb in multiple roles: as a Regulatory Affairs Associate Manager in 2021 for three months, and as a Senior Regulatory Affairs Specialist from 2018 to 2020 for two years. During his tenure, he gained substantial experience in managing the regulatory compliance for clinical trials, specifically focusing on both small molecules and biologics. His responsibilities included contributing to the development of regulatory documents such as Clinical Study Reports and Investigator Brochures.

Career at Pharma To Market Pty Ltd

From 2014 to 2017, Mitchell Green served as a Senior Regulatory Affairs Consultant at Pharma To Market Pty Ltd in Brisbane. Over three years, he provided consultancy services on regulatory compliance matters, leveraging his extensive knowledge in pharmacovigilance and regulatory affairs. His role required a thorough understanding of the regulatory landscape, ensuring that clients met all necessary guidelines and standards.

Academic Credentials

Mitchell Green holds an impressive array of academic qualifications. He earned a Master of Public Health (MPH) specializing in Health Economic Evaluation from UNSW in 2021. Additionally, he has a Graduate Certificate in Business Administration from Victoria University, achieved with a GPA of 6.75/7. His academic background also includes an Advanced Post Graduate Diploma in Pharmacovigilance and Regulatory Affairs from James Lind Institute (2016), a Graduate Certificate in Drug Development from UNSW (2013), and a Bachelor of Biomedical Science from the University of the Sunshine Coast, where he studied Medical Microbiology, Bacteriology, and Clinical Trial Management.

Industry Experience and Expertise

Mitchell Green brings a wealth of experience to the regulatory affairs sector. His career began as a Data Manager and Clinical Study Coordinator at the Gallipoli Medical Research Foundation. He has also held roles at Alphapharm and bioCSL, accumulating significant experience across diverse roles in regulatory compliance. His comprehensive understanding of the regulatory requirements in the Asia-Pacific region and his involvement in the preparation and submission of regulatory dossiers have established him as a reliable expert in his field.

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