Donghui Ni
Drexel University
Tell me more about Donghui Ni?
Donghui Ni is an experienced professional with 25.3 years of work experience in the pharmaceutical industry. He has expertise in regulatory affairs, clinical trials, and regulatory submissions. Currently, he serves as the Associate Director of Regulatory Affairs at Sanofi. Throughout his career, Donghui has held various senior positions at renowned companies such as Genmab, Bayer, MSD, and Sanofi. He has a strong background in biopharmaceuticals, oncology, and biotechnology. Donghui's extensive experience and skills make him a valuable asset in the field of regulatory affairs.
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About
Associate Director, Regulatory Affairs at Sanofi
Work Experience
Senior Director Regulatory Strategist
Biotechnology Research
Donghui Ni's Professional Milestones
- Regulatory Planning Manager (2007-10-01~2009-03-01): Implementing a comprehensive regulatory framework to support efficient decision-making and improve regulatory compliance.
- Senior Manager, Regulatory Affairs (2011-10-01~2015-05-01): Successfully navigated regulatory landscape, ensuring compliance and minimizing risk for the organization.
Education
Molecular Biology,
Master Of Science,
Masters
1995-1998Skill
Pharmaceutical Industry
Regulatory Affairs
Clinical Trials
Regulatory Submissions
Ectd
Ind
Biopharmaceuticals
Oncology
Biotechnology
Clinical Development
Regulatory Requirements
Resilience
Drug Development
Fda
Gcp
Technology Transfer
Life Sciences
Sop
Managing Workflow
Certification
Colleagues
Jodie Prestholdt
Senior Manager, Pathology Genmab; MS-HCM, BS, MLS(ASCP)CT,HTL Owner, AnaPath Consulting, LLC
Cristian Lizzio (He/Him)
human resources leader and certified professional coach | ceo and founder of nothing i just make it happen!
Jan van de Winkel, Ph.D.
President | Chief Executive Officer
Denise Migliaccio
Executive Assistant To Chief Operating Officer
David Eatwell
Chief Financial Officer | Executive Vice President
Other Named Donghui Ni
Frequently asked questions
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Donghui Ni's social media include: Linkedin,
Donghui Ni works for Genmab
Donghui Ni's role in Genmab is Senior Director Regulatory Strategist
Donghui Ni works in the industry of Biotechnology Research
Donghui Ni's colleagues are Jodie Prestholdt,Cristian Lizzio (He/Him),Jan van de Winkel, Ph.D.
Donghui Ni's latest job experience is Senior Director Regulatory Strategist at Genmab
Donghui Ni's latest education in Drexel University