Julia Gehrmann
Gra Cmc Manager Global Regulatory Affairs @CSL
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WORK HISTORY
Gra Cmc Manager Global Regulatory Affairs @CSL
Spearheaded the strategic regulatory oversight and compliance concerning Chemistry, Manufacturing, and Control (CMC) activities for plasma-derived human albumin products and their intermediates, ensuring global market access and uninterrupted supply through robust regulatory frameworks.Led the development and implementation of global CMC regulatory strategies for product development, new registrations, and relevant CMC projects, ensuring adherence to evolving global regulatory requirements.Provided expert technical guidance to Global Regulatory Affairs colleagues on CMC topics, optimizing submission processes and ensuring the highest quality standards for regulatory documentation (e.g, Module 3 updates, variations).(Transitioned to the Global GRA CMC Albumin Team (04/2023), further enhancing expertise with Alburex.)
EDUCATION
RWTH Aachen University
M. Sc. RWTH, Molecular and Applied Biotechnology
Universität zu Lübeck
B. Sc., Biotechnology
Queen's University
Research Internship Abroad - Glycobiology
Lette Verein Berlin
State examination - Vocational Training as MTLA (State Examination: Grade 2.1), Technical assistance for laboratory medicine (MTLA)
ABOUT JULIA GEHRMANN
Professional Track Record in GRA CMC (Chemistry, Manufacturing and Controls) since 2018, I specialize in the lifecycle management and strategic compliance of complex biologics. My professional journey is defined by - a unique combination of high-level strategic oversight and- a deep-rooted scientific foundation. Why I bring a unique perspective to CMC Scientific Depth? My PhD in Medical Biotechnology allows me to understand the molecular complexity of products from the ground up, ensuring that regulatory strategies are scientifically sound. My background as a Medical Laboratory Technician (MTLA) has instilled a \"precision-first\" mindset, which translates into exceptional high accuracy in change control assessments and global submissions.Global Impact: I have a proven track record of navigating complex regulatory landscapes (Module 3, eCTD) in the EU, China, Japan and various RoW markets, ensuring that life-saving therapies reach patients reliably and compliant. I am passionate about process optimization and digital excellence, utilizing tools like Veeva Vault and Trackwise to streamline global workflows. My work is driven by a deep sense of responsibility toward patient well-being and a commitment to sustainable, ethical corporate values.Let’s connect to discuss the future of Global Regulatory Affairs and sustainable innovation in the pharmaceutical industry.
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