Vinciane Wouters
Université catholique de Louvain
Tell me more about Vinciane Wouters?
Vinciane Wouters is a highly experienced professional with over 15 years of work in the lifesciences and regulatory affairs field. Based in Belgium, she has a strong background in clinical trials, regulatory affairs, and biotechnology. Vinciane has worked in various roles, including Director of Global Regulatory Strategy Eu Oncology and Associate Director of Global Regulatory Strategy Europe. She has also held positions at Bristol Myers Squibb and Cella?on, where she has demonstrated expertise in pre-marketing and clinical trials, as well as regulatory guidance for Advanced Therapy Medicinal Products (ATMP) and Pediatric drug development.
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About
Key skills:- More than 8 years within Regulatory Affairs- Experience of pre marketing and clinical trials- Experience in regulatory guidance for Advanced Therapy Medicinal Products (ATMP)- Clinical submissions in Europe and US- Pediatric drug development- Orphan drug Development- Scientific Advice Procedures with Regulatory Authorities
Work Experience
director regulatory liaison europe at msd belgium
Pharmaceutical Manufacturing
Vinciane Wouters's Professional Milestones
- Associate Director Global Regulatory Strategy Europe (2016-09-01~2021-10-01): Developing and implementing comprehensive regulatory strategies, safeguarding global business opportunities for European markets.
- Regulatory Affairs Manager (2011-01-01~2012-12-01): Successfully executed regulatory approvals and initiatives to ensure compliance and protect the organization's obligations and interests.
Education
Biomedical And Pharmaceutical Sciences,
Biomedical Sciences,
Molecular Biology
1996-2001Skill
Lifesciences
Regulatory Requirements
Clinical Trials
Regulatory Affairs
Biotechnology
Regulatory Submissions
Molecular Biology
Ind
Biopharmaceuticals
Clinical Development
Gmp
Pharmaceutical Industry
Clinical Research
Validation
Life Sciences
Vaccines
Gcp
Certification
Colleagues
Sarah Sneed
oncology business unit director belgium
Faisal Jamil
Director Regulatory Affairs
Henk Roets
associate director engineering msd
Erik Antonissen
clinical research director at msd belgium
An Cloet
external affairs director msd belux
Other Named Vinciane Wouters
Frequently asked questions
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Vinciane Wouters's social media include: Linkedin,
Vinciane Wouters works for MSD Belgium
Vinciane Wouters's role in MSD Belgium is director regulatory liaison europe at msd belgium
Vinciane Wouters works in the industry of Pharmaceutical Manufacturing
Vinciane Wouters's colleagues are Sarah Sneed,Faisal Jamil,Henk Roets
Vinciane Wouters's latest job experience is director regulatory liaison europe at msd belgium at MSD Belgium
Vinciane Wouters's latest education in Université catholique de Louvain