Marion Schöffel
Associate Director Regulatory Consulting@ Syneos Health
Neu Isenburg, Hessen, Germany
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Marion Schoffel is a highly experienced Line Manager of Regulatory Advisors/Subject Matter Experts on EUCTR/CTIS with 37.7 years of work experience. She has worked in various roles, including Senior Study Start-up Specialist at inVentiv Health Commercial and Senior Regulatory Expert at Syneos Health. Marion is skilled in Regulatory Strategies for complex studies and design studies, including GMO/ATMP/combination Drug/Device. She is also proficient in preparing CTA submissions, Master Label Review, Centralized Submissions, and Regulatory Impact Assessment in the Life Cycle Maintenance Phase. Marion has a strong background in Regulatory matters and intelligence.
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Emails and Phone Numbers

+49 191987****
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About

Line Manager of Regulatory Advisors/Subject Matter Experts on EUCTR/CTIS working in the Early Engagement Department on Regulatory Strategies for complex studies and/or complex design studies like GMO/ATMP/combination Drug/Device. Compiling the Core Documents for CTA submissions, Master Label Review, Centralized Submissions (EU CTR/CTIS), Regulatory Impact Assessment in the Life Cycle Maintenance Phase, serving as Expert on Regulatory matters and intelligence. CTIS Master Trainer

Work Experience

Michigan St Hammond, Indiana, US

Business Consulting and Services

164
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Marion Schöffel's Professional Milestones

  • Associate Director Regulatory Consulting (dec.-2015-01~okt.-2020-01): Developed effective regulatory strategies, ensuring compliance and minimizing risks for global companies.
  • Senior Study Start-up Specialist (okt.-2013-01~dec.-2015-01): Successfully delivered complex experiments of complex projects, bringing valuable insights and solutions to life.
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