Michael Z.
Head of Regulatory Affairs @ Innogen Pharmaceutical Technology
About
Proactive problem-solver and quick learner to fill the gaps among sponsors, regulators and patients.
China
Shanghai
Pharmaceuticals
Regulatory Submissions, Regulatory Strategy Development, Clinical Development, eCTD, ICH M Standards, Regulatory Intelligence, Business Development, Natural Language Processing (NLP), Machine Learning
Experience
Head of Regulatory Affairs
Innogen Pharmaceutical Technology
Director of Regulatory Affairs
Asieris Pharmaceuticals
Global Regulatory Affairs Leader
Widler & Schiemann AG
Basel, Switzerland
- Regulatory intelligence and expert advice on local regulatory requirements and procedures (US, EU, China) - Advice and execution of regulatory and submission strategy (local or global strategies) - Health Authority interactions and Regulatory Representative (China, US and EU et al) - Licensing, registration and maintenance - Post-market activities
Director, Global Regulatory Affairs & Intelligence Solution
Deep Intelligent Pharma
Shanghai City, China
- Global Regulatory Affairs Leader (Drugs, Biologics & Medical Device) - Regulatory Intelligence Solution (ARM - AI Regulatory Management) - Business Development
APAC Regulatory Submission Team Lead, Worldwide Safety and Regulatory
Pfizer
Shanghai City, China
- Team Lead for APAC Submission Management (mainland China) - Regulatory Strategic Planning and Project Management for chemical drugs and biologics (CTA/BLA/NDA and Post-marketing for mainland China) - Emerging Markets Regulatory Strategy & Submission Plan - APAC Translation Excellence Manager - Health Agency scientific advisory consultant for Global eSubmission standards - Regulatory Operation Excellence Champion
Hub Submission Manager, Worldwide Safety and Regulatory
Pfizer
Shanghai, China
- Global Regulatory Dossier Excellence Implementation (ICH & APAC) - Global Integrated Operation (GiO) design and implementation (APAC, Submission & Labeling) - Submission Readiness (Clinical, Regulatory & Labeling) - Regulatory Information Management - eDocument Management System SME - Clinical Study Report Coordination
Education
University of Oxford
Evidence-Based Health Care
Northeastern University
Regulatory Affairs for Drugs, Biologics, and Medical Devices
Shanghai Jiao Tong University
Biotechnology
Universität des Saarlandes
Chemistry
Michael Z.'s Contact Information
Phone
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