Daniel Orfe
President & CEO at Regulatory eSubmissions, LLC | Kulpsville, Pennsylvania, United States
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Daniel Orfe serves as the President and CEO of Regulatory eSubmissions, LLC, where he leverages his extensive background in regulatory submissions to drive innovation and efficiency in the life sciences sector. With a wealth of experience spanning emerging and global pharmaceutical companies as well as major submission software and services organizations, Daniel has honed his expertise in regulatory submissions strategy and business process improvements. His leadership is pivotal in guiding clients through the complexities of electronic regulatory submissions, particularly in the production and management of Electronic Common Technical Documents (eCTD).
Under Daniel's stewardship, Regulatory eSubmissions, LLC has embarked on key projects that focus on enhancing the efficiency of regulatory operations. His commitment to outsourcing and vendor management allows organizations to optimize their resources while ensuring compliance with FDA regulations, including the stringent requirements of 21 CFR Part 11. Daniel's proficiency in business process analysis and change management empowers clients to transition seamlessly from strategic goals to tactical operations, resulting in streamlined eCTD documentation and assembly.
Daniel's approach is characterized by a deep understanding of the regulatory landscape and a passion for fostering collaborative partnerships. He is dedicated to providing comprehensive training in eCTD solutions and strategic assessments of regulatory operations, ensuring that organizations not only meet compliance standards but also achieve innovative improvements. With a focus on effective regulatory affairs and standard operating procedures (SOP), Daniel Orfe is a transformative leader in the regulatory submissions field, committed to advancing the industry's standards and practices.
President & CEO at Regulatory eSubmissions, LLC in August 2013 to Present
Associate Director, Global Regulatory Operations at Teva Pharmaceuticals in September 2011 to July 2013
Vice President, Global Regulatory Submission Services at Datafarm Inc in January 2009 to March 2010
Associate Director, Worldwide Regulatory Operations at Merck in October 1996 to October 2008
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eCTD
Regulatory Submissions
Document Management
Business Analysis
Lifesciences
FDA
Pharmaceutical Industry
21 CFR Part 11
IND
Process Improvement
Regulatory Requirements
Vendor Management
Strategy
Computer System Validation
Pharmaceutics
Software Documentation
Regulations
Regulatory Affairs
Business Process
Sop
SDLC
Business Process Improvement
Life Sciences
Electronic Common Technical Document (eCTD)
SOP
U.S. Title 21 CFR Part 11 Regulation
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Software Development Life Cycle (SDLC)
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Discover more about Regulatory eSubmissions, LLCWhat is Daniel Orfe email address?
Email Daniel Orfe at [email protected]. This email is the most updated Daniel Orfe email found in 2026.
What is Daniel Orfe phone number?
Daniel Orfe phone number is +12152801483 and +12155344600.
How to contact Daniel Orfe?
To contact Daniel Orfe send an email to [email protected]. If you want to call Daniel Orfe try calling on +12152801483 and +12155344600. (updated on November 04, 2024)
What is Daniel Orfe net worth?
Daniel Orfe has an estimated net worth of $750,000 to $999,999
What company does Daniel Orfe work for?
Daniel Orfe works for Regulatory eSubmissions, LLC
What is Daniel Orfe's role at Regulatory eSubmissions, LLC?
Daniel Orfe is President & CEO
What industry does Daniel Orfe work in?
Daniel Orfe works in the Pharmaceutical Manufacturing industry.
Daniel Orfe Email Addresses
Daniel Orfe Phone Numbers
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