Manager, Regulatory Advertising And Promotional Policy, Specialty Unit
Current
Jan 2022 - Present
AeroLeads people directory · profile
Danielle Mckee Email & Phone Number
Regulatory Advertising and Promotional Policy at GSK
at
GSK
1 work email found
@gsk.com
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 86%
Current company
Role
Regulatory Advertising and Promotional Policy at GSK
Location
Pottstown, Pennsylvania, United States
Who is Danielle Mckee? Overview
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Quick answer
Danielle Mckee is listed as Regulatory Advertising and Promotional Policy at GSK at GSK, based in Pottstown, Pennsylvania, United States. AeroLeads shows a work email signal at gsk.com and a matched LinkedIn profile for Danielle Mckee.
Danielle Mckee previously worked as Manager, Regulatory Advertising and Promotional Policy, Specialty Unit at Gsk and Regulatory Affairs Project Manager at Gsk. Danielle Mckee holds Masters Of Science Degree, Regulatory Affairs/Quality Assurance from Temple University.
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Email format at GSK
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{first}.{last}@gsk.com
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Profile bio
About Danielle Mckee
Danielle Mckee is a Regulatory Advertising and Promotional Policy at GSK at GSK.
Current workplace
Danielle Mckee's current company
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8 roles · 30 years
Danielle Mckee work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs Project Manager
Current- Global Project Team CMC Regulatory representative
- Responsible for CMC Regulatory activities of assigned projects across multiple dosage forms.
- Represents GNS on assigned CMC Regulatory matters/tasks. Communicates across GSK as necessary to advise on CMC project and policy issues.
- Provides regulatory advice and guidance to Preclinical Development (PCD), Worldwide Development (WWD) and Global Manufacturing and Supply (GMS) PPD teams to produce assigned CMC components of global regulatory dossiers.
- Effectively plans, coordinates and delivers completed CMC components of global regulatory documents according to company/project timelines with appropriate support from line manager.
- Understands regulations, guidelines, procedures and policies relating to development registration and manufacturing pharmaceutical products.
Jul 2008 - Present
Senior Regulatory Associate
- Compile, Create and Distribute regulatory surveillance information from all health authorities via Regulatory Intelligence Newsletter
- Maintain compliance and ensure all Regulatory standards are met for outgoing submissions (NDA, sNDA, IND, PAS, DMF, CBE-30, Citizen’s Petition and Annual Reports)
- Complete and submit all site Establishment registrations and renewals
- Created and ensure maintenance of project status from a regulatory perspective
- Attend project team meetings as a Regulatory representative
- Train less experienced employees in Regulatory affairs processes and procedures
Jan 2005 - Jul 2008
Associate Scientist
- Created data tracking database
- Preclinical NDA internal quality checks
- IND submission internal Preclinical auditing
- Internal QC Checks of raw data notebooks
- Micromedex System Coordinator for training and usage
- Coordinate all aspects of study-related activities with study director (protocol and amendment preparation, order supplies, study conduct, analyze data, write report, data archival)
Jun 2000 - Jan 2005
Research Scientist
- Created test article inventory tracking system
- Perform routine internal QC Checks on raw data notebooks, prior to QA Audit, to ensure compliance of all regulations
- Coordinate all aspects of study-related activities with study director (GLP and non-GLP studies)
- Formulate and administer test materials to lab animals using various routes
- Follow Standard Operating Procedures (SOP’s), and Good Laboratory Practices (GLP’s)
- Reproductive Toxicology, Clinical Pathology, Morphologic Pathology, DMPK
Nov 1998 - Jun 2000
Biological Technician - Toxicology
- Follow study protocols, standard operating procedures, and Good Laboratory Practices (GLP’s)
- Communicate study results to the Study Director
- Administer test materials to lab animals through various routes
Nov 1997 - Nov 1998
Product Specialist
1996 - 1997
~1 yr
Product Specialist
1996 - 1997
~1 yr
2 education records
Danielle Mckee education
Masters Of Science Degree, Regulatory Affairs/Quality Assurance
Temple University
Bachelor Of Science, Biology
Delaware Valley University
FAQ
Frequently asked questions about Danielle Mckee
Quick answers generated from the profile data available on this page.
What company does Danielle Mckee work for?
Danielle Mckee works for GSK.
What is Danielle Mckee's role at GSK?
Danielle Mckee is listed as Regulatory Advertising and Promotional Policy at GSK at GSK.
What is Danielle Mckee's email address?
AeroLeads has found 1 work email signal at @gsk.com for Danielle Mckee at GSK.
Where is Danielle Mckee based?
Danielle Mckee is based in Pottstown, Pennsylvania, United States while working with GSK.
What companies has Danielle Mckee worked for?
Danielle Mckee has worked for Gsk, Mcneil Consumer Healthcare, Johnson & Johnson, Sanofi-Aventis, and Bristol-Myers Squibb, Princeton, New Jersey.
How can I contact Danielle Mckee?
You can use AeroLeads to view verified contact signals for Danielle Mckee at GSK, including work email, phone, and LinkedIn data when available.
What schools did Danielle Mckee attend?
Danielle Mckee holds Masters Of Science Degree, Regulatory Affairs/Quality Assurance from Temple University.
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