Marlene Nebiker Panchaud
Regulatory Affairs Manager at Curatis AG- Claim this Profile
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Spanish Native or bilingual proficiency
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German Native or bilingual proficiency
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English Full professional proficiency
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French Full professional proficiency
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Italian Limited working proficiency
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Bio
Experience
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Curatis AG
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Switzerland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Manager
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Jan 2023 - Present
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Bayer
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Chemical Manufacturing
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700 & Above Employee
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Regulatory Affairs Specialist
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Jan 2018 - Jan 2023
Responsible to coordinate, manage and provide the relevant regulatory documentation to maintain the life cycle management of existing products as well as to enable the registration of new products worldwide.• Complete Regulatory responsibility of assigned brands (Rennie and Elevit).• Experience with Medicinal products, Medical Device, and food supplements. • Ensuring that regulatory strategy and activities are aligned with stakeholders such as Product Supply, Quality, CMC- Medical - or Pharmacovigilance Experts.• Ensuring that the registration information is properly prepared, maintained and entered into the data management system.• Maintenance and compliance of worldwide marketing authorizations.Achievements:• Rennie Expansion via Mutual Recognition Procedure (MRP).• TüV Audits without major findings.• Ongoing Elevit Stork expansion in the Middle East.• Site transfer to protect sales loss and maintenance of production in EU countries (definition of regulatory strategy and its implementation). Show less
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Regulatory Affiliate Specialist Dermatology - Analgesics and Nutritionals
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Aug 2014 - Dec 2017
-Proactively coordinating and providing documentation to support new registrations, renewals, variations and other regulatory requirements.-Monitoring renewals.-Tracking all affiliate dispatches and registration activities for RA.
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Université de Fribourg - Universität Freiburg
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Switzerland
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Higher Education
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700 & Above Employee
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Graduate Assistant
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Jul 2010 - Jun 2014
-Investigated the role of endothelial cells and the AKT Signaling Pathway in promoting breast cancer, cell growth, invasion and metastasis in Mammalian cell culture and mice. -Supervised the work of a bachelor student. -Protocol preparation, bibliography, data analysis. -Coorganized the first Fribourg Career Day in Life Sciences. -Investigated the role of endothelial cells and the AKT Signaling Pathway in promoting breast cancer, cell growth, invasion and metastasis in Mammalian cell culture and mice. -Supervised the work of a bachelor student. -Protocol preparation, bibliography, data analysis. -Coorganized the first Fribourg Career Day in Life Sciences.
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FIFF, Fribourg International Film Festival
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Switzerland
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Artists and Writers
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1 - 100 Employee
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Hospitality Assistant
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Jan 2010 - Mar 2010
- Organized the travel and scheduled the stay of film directors and actors. - Welcoming and assisting film directors and actors. - Interpreter (interpreting synchronously from and to French, German, English and Spanish) - Organized the travel and scheduled the stay of film directors and actors. - Welcoming and assisting film directors and actors. - Interpreter (interpreting synchronously from and to French, German, English and Spanish)
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Voluntary Trainee
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Jun 2009 - Oct 2009
- Field work on Anthrax and Brucellosis. - Field work on Anthrax and Brucellosis.
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Education
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University of Fribourg
Master of Science (M.Sc.), Cell/Cellular and Molecular Biology -
University of Fribourg
Bachelor of Science (B.Sc.), Biology