Rebecca Sagosz
Regulatory Affairs/Operations Consultant
- Role
- Senior Manager, Regulatory Affairs - Grst at Immunovant
- Location
- Jonesborough, TN, US
- LinkedIn followers
- 500 followers
About Rebecca Sagosz
Experienced Regulatory Affairs/Operations professional with a demonstrated history of working in the life sciences industry. Strategic thinker with extensive experience in development and implementation of regulatory affairs/operations strategies and systems to support timely introduction and submission of new products. Strong project management, contract management and business development experience.
Experience
Senior Manager, Regulatory Affairs - Grst
Aug 2024 — Present · New York, NY, US
Education
Penn State University
AS, Business Law
University of Phoenix
BS
Skills
- Clinical Research
- Regulatory Requirements
- Ind
- Strategy
- Clinical Trial Management System (Ctms)
- Standard Operating Procedure (Sop)
- Pharmaceutics
- Pharmacovigilance
- Gmp
- Edc
- Ctms
- Document Management
- 21 Cfr Part 11
- Gcp
- Regulations
- U.s. Title 21 Cfr Part 11 Regulation
- Change Control
- U.s. Food and Drug Administration (Fda)
- Validation
- Computer System Validation
- Oncology
- Clinical Development
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Data Management
- Clinical Data Management
- Technology Transfer
- Regulatory Affairs
- Lifesciences
- Life Sciences
- CRO Management
- Ectd
- Regulatory Submissions
- Strategic Technology Development
- Clinical Trials
- Technology Integration
- Good Clinical Practice (Gcp)
- Electronic Common Technical Document (Ectd)
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