Fran Quinn
Director at Pfizer Submission Mgmt and compliance
- Role
- Director Us Lifecycle Sm and Compliance at 辉瑞
- Location
- Pottstown, PA, US
- LinkedIn followers
- 500 followers
Experience
Director Us Lifecycle Sm and Compliance
Jun 2025 — Present · Collegeville, PA, US
Director leading Global teams across multiple countries and time zones to oversee and manage the US Portfolio concentrating on Lifecycle and compliance submissions across IND and Marketed products. Also lead a parallel global teams supporting Annual Reporting Contributions collections including all NDA, BLA, PADERS. Drug Listing, CARES ACT and SPL Creation.
Education
Villanova University
Bachelor of Science, Leadership
2003 — 2008
Skills
- Regulatory Requirements
- Ind
- Vaccines
- CRO
- Ich Guidelines
- 21 Cfr
- Ectd
- Pharmaceutical Industry
- Sop
- Fda
- Ich-Gcp
- Document Management
- Project Portfolio Management
- Regulatory Affairs
- Nda
- Isi Toolbox
- Process Improvement
- Nees
- Data Management
- Sharepoint
- Regulatory Documentation
- Validation
- Microsoft Office
- Adobe Acrobat
- Medical Writing
- Drug Development
- Gcp
- Clinical Trials
- Regulatory Filings
- Software Documentation
- Ctms
- Regulatory Submissions
- Leadership
- Pharmacovigilance
- 21 Cfr Part 11
- Regulations
- Cross-Functional Team Leadership
- Computer System Validation
- Anda
- R
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