Lee Ralph
Senior Manager, Submissions Lead Turkiye & CauCAR, GRS Submissions Management at Pfizer | Margate, England, United Kingdom
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Lee Ralph serves as the Senior Manager and Submissions Lead for Türkiye and CauCAR within Pfizer's Global Regulatory Solutions (GRS) Submissions Management team. In this pivotal role, Lee is responsible for the oversight and delivery of a diverse submissions portfolio, which includes both major initial submissions and lifecycle dossiers. His extensive expertise in regulatory submissions spans multiple formats and filing routes, including eCTD, NeeS, and traditional paper submissions, making him a subject matter expert in the field.
With a proven track record of coordinating and executing complex regulatory submissions across the EU, Australia, Switzerland, and emerging markets, Lee has successfully navigated the intricacies of compliance and regulatory frameworks. His role involves meticulous adherence to key performance indicators (KPIs) and metrics reporting, ensuring that all submissions meet stringent regulatory standards. Lee's commitment to operational excellence is evident in his strategic planning and implementation of regulatory process redesigns, aimed at enhancing efficiency and effectiveness within the submissions lifecycle.
In addition to his technical skills, Lee brings two years of people management experience, fostering collaboration and continuous improvement among cross-functional teams. His leadership extends beyond his immediate responsibilities, as he serves as the eSubmissions industry chair for the MERN (Medical Electronic Regulatory Network), where he advocates for best practices and innovation in electronic submissions. Lee’s blend of regulatory expertise, project management acumen, and a keen focus on compliance positions him as a vital asset to Pfizer and the broader pharmaceutical industry.
Senior Manager, Submissions Lead Turkiye & CauCAR, GRS Submissions Management at Pfizer in March 2024 to Present
Senior Manager, Submissions Lead Gulf & ELI, Worldwide Regulatory Operations at Pfizer in October 2014 to March 2024
EU Submissions (CAP) Team Manager, Worldwide Safety & Regulatory at Pfizer in February 2014 to October 2014
AfME Submissions Team Manager, Worldwide Safety & Regulatory at Pfizer in February 2012 to February 2014
Manager, Submissions at Pfizer in January 2011 to February 2012
Senior Associate, Submissions at Pfizer in January 2004 to January 2011
Entertainment Manager at Woolworths in January 1995 to January 1999
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Operational Excellence
Project Planning
Interpersonal Skills
Communication
Project Metrics
Key Performance Indicators
Quality Assurance
Timelines
Project Plans
Defining Requirements
Common Technical Document (CTD)
eCTD
Regulatory Submissions
Compliance
Regulatory Strategy
Regulatory Requirements
NeeS
eCTDXpress
ISI Publisher
MRP
CAP
National
Clinical Development
Strategy
Regulatory Affairs
21 CFR Part 11
Sop
Pharmacovigilance
Project Management
Standard Operating Procedure (SOP)
Management
Pharmaceutical Industry
SOP
Clinical Trials
Electronic Common Technical Document (eCTD)
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Discover more about PfizerWhat is Lee Ralph email address?
Email Lee Ralph at [email protected] and [email protected]. This email is the most updated Lee Ralph email found in 2026.
How to contact Lee Ralph?
To contact Lee Ralph send an email to [email protected] or [email protected].
What company does Lee Ralph work for?
Lee Ralph works for Pfizer
What is Lee Ralph's role at Pfizer?
Lee Ralph is Senior Manager, Submissions Lead Turkiye & CauCAR, GRS Submissions Management
What is Lee Ralph's Phone Number?
Lee Ralph's phone +44 ** **** *248
What industry does Lee Ralph work in?
Lee Ralph works in the Pharmaceutical Manufacturing industry.
Lee Ralph Email Addresses
Lee Ralph Phone Numbers
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