Emily Duritza
Senior Regulatory Affairs Specialist at Viatris | United States
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Emily Duritza is a dedicated Senior Regulatory Affairs Specialist at Viatris, where she leverages her extensive knowledge in biology and regulatory compliance to navigate the complex landscape of pharmaceutical submissions. Graduating from Pennsylvania State University with a Bachelor of Science in Biology in December 2014, Emily has cultivated a robust skill set that includes expertise in preparing regulatory submissions to the U.S. Food and Drug Administration (FDA). Her role involves the meticulous preparation of Abbreviated New Drug Applications (ANDAs), as well as various supplements such as Changes Being Effected (CBE), Changes Being Effected in 30 Days (CBE-30), and Prior Approval Supplements (PAS).
Emily’s commitment to maintaining compliance with Good Manufacturing Practices (GMP) is evident in her daily responsibilities, which include drafting Annual Reports and managing both Administrative and Product Correspondences. Her proficiency in reviewing labels ensures that all product information meets regulatory standards, thereby safeguarding public health and enhancing product efficacy.
In addition to her regulatory expertise, Emily is skilled in utilizing advanced analytical techniques, including GC-MS and UV/Vis spectroscopy, which support her understanding of product formulation and quality assurance. Her strong communication and presentation skills enable her to effectively collaborate with cross-functional teams, ensuring that all regulatory strategies align with Viatris's overarching goals. Through her work, Emily not only contributes to the successful launch of new pharmaceutical products but also plays a pivotal role in fostering a culture of compliance and excellence within the organization.
Senior Regulatory Affairs Specialist at Viatris in June 2016 to Present
Regulatory Affairs Coordinator at Bay Valley Foods in August 2015 to June 2016
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Penn State University, Bachelor's Degree, July 2026
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Reviewing Labels
Creating Regulatory Label Copies (RLCs)
Creating Ingredient Statements
SAP
Genesis
TraceGains
Microsoft Outlook
Microsoft Excel
Microsoft Word
Microsoft Power Point
Team-player
Communication Skills
Writing Skills
Presentation Skills
Task and Goal Oriented
Training/Teaching Others
Biology
Molecular Biology
Cell Biology
Microbiology
Bacterial Cell Culture
Microscopes
Anatomy
Physiology
Chemistry
Organic Chemistry
Melting Point
GC-MS
UV/Vis
Pipetting
U.S. Food and Drug Administration (FDA)
Regulatory Affairs
Pharmaceutical Industry
Trackwise
Good Manufacturing Practice (GMP)
Lorenz
Standard Operating Procedure (SOP)
Documentum Compliance Manager (DCM)
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Discover more about ViatrisWhat is Emily Duritza email address?
Email Emily Duritza at [email protected]. This email is the most updated Emily Duritza's email found in 2026.
How to contact Emily Duritza?
To contact Emily Duritza send an email to [email protected]. (updated on September 04, 2024)
What company does Emily Duritza work for?
Emily Duritza works for Viatris
What is Emily Duritza's role at Viatris?
Emily Duritza is Senior Regulatory Affairs Specialist
What is Emily Duritza's Phone Number?
Emily Duritza's phone (***) ***-*133
What industry does Emily Duritza work in?
Emily Duritza works in the Pharmaceuticals industry.
Emily Duritza Email Addresses
Emily Duritza Phone Numbers
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