Krista Cole
Director (Principal Scientist), Regulatory Affairs International at Merck | Souderton, Pennsylvania, United States
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Krista Cole serves as the Director (Principal Scientist) of Regulatory Affairs International at Merck, where she plays a pivotal role in navigating the complex landscape of global regulatory requirements for diagnostics and devices, particularly within the oncology sector. With her extensive experience in regulatory affairs, Krista is adept at managing the intricacies of regulatory submissions, ensuring compliance with both U.S. Food and Drug Administration (FDA) standards and international guidelines. Her expertise extends to Chemistry, Manufacturing, and Controls (CMC) regulatory affairs, which is crucial for the development of innovative therapies and companion diagnostics (CDx) that enhance patient outcomes.
In her current role, Krista leads key projects that involve the strategic planning and execution of regulatory submissions for oncology diagnostics, working closely with cross-functional teams to streamline processes and improve business operations. Her strong background in Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) allows her to effectively oversee the regulatory aspects of clinical trials and product development, ensuring that all activities meet stringent regulatory requirements. Krista thrives in high-pressure, deadline-driven environments, leveraging her skills in change control and standard operating procedures (SOP) to foster a culture of compliance and continuous improvement.
As a seasoned professional in the pharmaceutical industry, Krista is not only a regulatory affairs expert but also a proactive leader who champions the importance of regulatory strategy in driving innovation. Her commitment to advancing oncology diagnostics positions her as a key player in Merck's mission to transform patient care through groundbreaking therapies and diagnostics.
Director (Principal Scientist), Regulatory Affairs International at Merck in May 2021 to Present
Associate Director Regulatory Affairs International at Merck in April 2017 to May 2021
Associate Director, Regulatory Submissions Management, CMC Project Manager at Merck in November 2013 to April 2017
Sr. Specialist, Regulatory Affairs, Global Dossier Management (SDL) at Merck in June 2013 to November 2013
Specialist, Global CMC Regulatory Scientist at Merck in November 2009 to May 2013
Staff Biologist, Pathology at Merck in August 2007 to October 2009
Manager, Labeling Compliance at URL Pharma, Inc. in April 2006 to August 2007
Regulatory Affairs Associate at URL Pharma, Inc. in November 2004 to April 2006
Research Associate/Team Leader/Laboratory Technician at Charles River Laboratories in January 2001 to November 2004
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GMP
Regulatory Submissions
Pharmaceutical Industry
GLP
Regulatory Affairs
FDA
SOP
Regulatory Requirements
GCP
Change Control
Sop
Standard Operating Procedure (SOP)
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Business Process Improvement
CMC Regulatory Affairs
IND
Cross-functional Coordination
CMC
Companion Diagnostics (CDx)
In Vitro Diagnostics (IVD)
Organization & prioritization skills
Global Regulations
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Discover more about MerckWhat is Krista Cole email address?
Email Krista Cole at [email protected] and [email protected]. This email is the most updated Krista Cole email found in 2026.
What is Krista Cole phone number?
Krista Cole phone number is +15082923991 and +15082922399.
How to contact Krista Cole?
To contact Krista Cole send an email to [email protected] or [email protected]. If you want to call Krista Cole try calling on +15082923991 and +15082922399.
What is Krista Cole net worth?
Krista Cole has an estimated net worth of $150,000 to $249,999
What company does Krista Cole work for?
Krista Cole works for Merck
What is Krista Cole's role at Merck?
Krista Cole is Director (Principal Scientist), Regulatory Affairs International
What industry does Krista Cole work in?
Krista Cole works in the Pharmaceutical Manufacturing industry.
Krista Cole Email Addresses
Krista Cole Phone Numbers
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