Simone Biel
Senior Regulatory Consultant at Merck KGaA, Darmstadt, Germany | Darmstadt, Hesse, Germany
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Simone Biel currently serves as a Senior Regulatory Consultant at Merck KGaA in Darmstadt, Germany, where she plays a pivotal role in guiding the company’s innovative biopharmaceutical and biotechnology initiatives through complex regulatory landscapes. Her expertise is particularly focused on Single-Use Technology and Cell and Gene Therapy, areas that are rapidly transforming the landscape of personalized medicine and advanced therapeutics. In her role, Simone provides strategic regulatory guidance to internal R&D teams and external clients, ensuring compliance with global regulatory standards such as those set by the FDA and EMA, while facilitating the development and approval of cutting-edge biopharmaceutical products.
A key aspect of her work involves navigating the regulatory requirements for validation processes related to bioprocessing and manufacturing of biopharmaceuticals, including chromatography and other purification techniques. She leverages her deep understanding of medical devices and regulatory frameworks to streamline product development timelines, mitigate compliance risks, and support successful submissions for clinical trials and market authorization. Simone’s expertise in research and development (R&D) enables her to advise on the regulatory implications of innovative technologies, including the integration of Single-Use Systems and advanced bioprocessing platforms.
Her comprehensive knowledge of FDA regulations and her ability to translate scientific data into clear regulatory strategies make her a trusted partner for stakeholders across the biopharmaceutical industry. By combining her skills in validation, biotechnology, and regulatory science, Simone Biel continues to contribute significantly to Merck’s mission of advancing healthcare solutions through innovative and compliant biotechnological advancements.
Senior Regulatory Consultant at Merck KGaA, Darmstadt, Germany in June 2020 to Present
Field Marketing Single Use Technology at Merck Life Science in January 2013 to June 2020
Technical Sales Consultant Single Use Technology at Merck Life Science in January 2011 to December 2012
Senior Application Specialist Biomonitoring at Merck Life Science in January 2006 to December 2010
Research and postdoctoral research assistant at Johann Wolfgang Goethe University in January 1996 to August 2003
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Goethe University Frankfurt, PhD, September 1990 to September 2026
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Life Sciences
Pharmaceutical Industry
Validation
Microbiology
Biopharmaceuticals
Single Use Technology
Biotechnology
Technology Transfer
Chromatography
FDA
GMP
U.S. Food and Drug Administration (FDA)
Molecular Biology
Protein Purification
Medical Devices
Research and Development (R&D)
Cell Culture
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Discover more about Merck KGaA, Darmstadt, GermanyWhat is Simone Biel email address?
Email Simone Biel at [email protected]. This email is the most updated Simone Biel's email found in 2026.
How to contact Simone Biel?
To contact Simone Biel send an email to [email protected]. (updated on March 07, 2025)
What company does Simone Biel work for?
Simone Biel works for Merck KGaA, Darmstadt, Germany
What is Simone Biel's role at Merck KGaA, Darmstadt, Germany?
Simone Biel is Senior Regulatory Consultant
What is Simone Biel's Phone Number?
Simone Biel's phone (**) *** *** 803
What industry does Simone Biel work in?
Simone Biel works in the Pharmaceuticals industry.
Simone Biel Email Addresses
Simone Biel Phone Numbers
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