Helen Bronder
Senior Regulatory Affairs Manager at AbbVie
- Role
- Senior Manager Regulatory Affairs at AbbVie
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
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About Helen Bronder
Project Management Professional (PMP) with a proven track record of successfully managing…
Experience
Senior Manager Regulatory Affairs
Sep 2022 — Present
Education
DePaul University
Master of Business Administration (M.B.A.)
St. Norbert College
Bachelor of Science (BS)
Marquette University
Master of Science (M.S.)
Skills
- Drug Development
- Biopharmaceuticals
- Good Laboratory Practice (Glp)
- Process Improvement
- Project Management Professional (Pmp Certified)
- 21 Cfr Part 11
- Validation
- U.s. Title 21 Cfr Part 11 Regulation
- Standard Operating Procedure (Sop)
- Management
- Team Building
- Fda Gmp
- Technology Transfer
- Regulatory Requirements
- Change Control
- Regulatory Submissions
- Pmp
- Leadership
- U.s. Food and Drug Administration (Fda)
- Glp
- Program Management
- Product Launch
- Gxp
- CRO
- Cross-Functional Team Leadership
- Change Management
- Regulatory Affairs
- V&V
- Biotechnology
- Forecasting
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Budgets
- Project Planning
- Capa
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